Methods and systems for aligning a commissure of a prosthetic heart valve with a commissure of a native valve

ABSTRACT

Methods and systems for rotationally aligning a commissure of a prosthetic heart valve with a commissure of a native valve are disclosed. In some examples, a delivery apparatus can include a first shaft configured to rotate around a central longitudinal axis of the delivery apparatus, a second shaft extending through the first shaft and having a distal end portion extending distally beyond a distal end portion of the first shaft, an inflatable balloon coupled to the distal end portion of the first shaft, and a third shaft surrounding the first shaft. The first shaft is configured to rotate within the third shaft and translate axially relative to the third shaft, and the third shaft includes a distal tip portion including a plurality of internal helical expansion grooves and a plurality of external helical expansion grooves that are configured to allow the distal tip portion to flex radially outward.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of PCT Application No.PCT/US2021/047056, filed Aug. 23, 2021, which claims the benefit of U.S.Provisional Patent Application Nos. 63/138,890, filed Jan. 19, 2021, and63/069,567, filed Aug. 24, 2020, which are incorporated by referenceherein in their entireties. PCT Application Nos. PCT/US2021/047063 andPCT/US2021/047068 are also incorporated by reference herein in theirentireties.

FIELD

The present disclosure relates to prosthetic heart valves and methodsfor deploying a balloon-expandable prosthetic heart valve at a nativevalve with a delivery apparatus such that a commissure of the radiallyexpanded prosthetic heart valve is aligned with a commissure of thenative valve.

BACKGROUND

The human heart can suffer from various valvular diseases. Thesevalvular diseases can result in significant malfunctioning of the heartand ultimately require repair of the native valve or replacement of thenative valve with an artificial valve. There are a number of knownrepair devices (e.g., stents) and artificial valves, as well as a numberof known methods of implanting these devices and valves in humans.Percutaneous and minimally-invasive surgical approaches are used invarious procedures to deliver prosthetic medical devices to locationsinside the body that are not readily accessible by surgery or whereaccess without surgery is desirable. In one specific example, aprosthetic heart valve can be mounted in a crimped state on the distalend of a delivery device and advanced through the patient's vasculature(e.g., through a femoral artery and the aorta) until the prostheticvalve reaches the implantation site in the heart. The prosthetic valveis then expanded to its functional size, for example, by inflating aballoon on which the prosthetic valve is mounted.

When deploying the prosthetic valve at the native valve by inflating theballoon of the delivery device, the radially expanded prosthetic valveis deployed at a random radial orientation relative to the native valve.As such, in some embodiments, one of the commissures of the prostheticvalve may be arranged in front of (e.g., adjacent to) a coronary ostiumof the aorta. This arrangement may reduce coronary access (e.g., bloodflow to the coronary arteries from the aorta) and/or create difficultiesduring future cardiovascular interventions that aim to maintain orincrease coronary access.

Accordingly, a need exists for improved delivery apparatuses and methodsfor deploying balloon-expandable prosthetic heart valves in a desiredrotational orientation relative to the native valve, such thatprosthetic heat valve commissures are in alignment with the native valvecommissures.

SUMMARY

Described herein are embodiments of improved prosthetic valve deliveryapparatuses and methods for delivering a prosthetic valve to andimplanting the prosthetic valve at a native valve of a heart of apatient with one or more selected commissures of the prosthetic valve inalignment with one or more corresponding commissures of the nativevalve. In some embodiments, the disclosed delivery apparatuses includean inflatable balloon that the prosthetic valve can be mounted around,in a radially compressed state, for delivery to the native valve. Afterreaching the native valve, a portion of the delivery apparatus and/orthe prosthetic valve can be rotationally aligned at or proximate to thenative valve such that after deploying the prosthetic valve viainflating the balloon of the delivery apparatus, one or more commissuresof the prosthetic valve are aligned (e.g., in a circumferentialdirection) with one or more commissures of the native valve.

In one representative embodiment, a delivery apparatus comprises a firstshaft configured to rotate around a central longitudinal axis of thedelivery apparatus to rotationally align a prosthetic valve mounted onthe delivery apparatus with native anatomy at a target implantationsite; a second shaft extending through the first shaft and having adistal end portion extending distally beyond a distal end portion of thefirst shaft; an inflatable balloon coupled to the distal end portion ofthe first shaft; and a polymeric body mounted on the distal end portionof the second shaft and a radiopaque marker mounted on or embeddedwithin the polymeric body.

In another representative embodiment, a medical assembly for replacing anative valve of a heart comprises a delivery apparatus. The deliveryapparatus comprises: a first shaft configured to rotate around a centrallongitudinal axis of the delivery apparatus; a second shaft extendingthrough the first shaft and having a distal end portion extendingdistally beyond a distal end portion of the first shaft; an inflatableballoon coupled to the distal end portion of the first shaft; and aradiopaque marker arranged on a distal end portion of the deliveryapparatus.

The medical assembly further comprises a prosthetic heart valve mountedin a radially compressed configuration onto and around the balloon. Themarker is offset, in a circumferential direction relative to the centrallongitudinal axis, from a location of a selected commissure of theprosthetic heart valve. The first shaft is configured to rotate torotationally align the marker at the native valve such that, afterinflating the balloon to radially expand the prosthetic heart valve, theprosthetic heart valve is implanted with the selected commissure of theprosthetic heart valve circumferentially aligned with a targetcommissure of the native valve.

In another representative embodiment, a delivery apparatus comprises ahandle portion and a rotatable shaft extending distally from the handleportion and having a proximal end portion that extends proximally fromthe handle portion to an adaptor. The adaptor includes a body connectedto the proximal end portion, a first port extending axially from thebody, and a second port extending at an angle from the body, in adirection intersecting a central longitudinal axis of the deliveryapparatus. The delivery apparatus further comprises a knob mounted onthe proximal end portion of the rotatable shaft, distal to the adaptor,the knob configured to rotate the rotatable shaft. The deliveryapparatus further comprises an inflatable balloon coupled to a distalend portion of the rotatable shaft and configured to inflate uponreceiving inflation fluid from the second port.

The foregoing and other objects, features, and advantages of thedisclosed technology will become more apparent from the followingdetailed description, which proceeds with reference to the accompanyingfigures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a prosthetic heart valve, according toone embodiment.

FIG. 2A is a perspective view of a prosthetic heart valve, according toanother embodiment.

FIG. 2B is a perspective view of the prosthetic valve of FIG. 2A withthe components on the outside of the frame shown in transparent linesfor purpose of illustration.

FIG. 3 is a perspective view of a delivery apparatus for a prostheticheart valve, according to an embodiment.

FIG. 4 is a schematic of an exemplary heart showing a position ofcoronary arteries relative to an aortic valve.

FIG. 5A illustrates an exemplary positioning of a prosthetic valve in anaortic valve, relative to a coronary artery.

FIG. 5B illustrates another exemplary positioning of a prosthetic valvein an aortic valve, relative to a coronary artery, where the prostheticvalve at least partially inhibits blood flow to the coronary artery.

FIG. 6A is a cross-sectional view of an aortic valve illustrating afirst positioning of a prosthetic valve within the aortic valve wherecommissures of the prosthetic valve at least partially block one or moreopenings to the coronary arteries.

FIG. 6B is a cross-sectional view of an aortic valve illustrating asecond positioning of a prosthetic valve within the aortic valve wherecommissures of the prosthetic valve are circumferentially aligned withnative commissure of the aortic valve, thereby maintaining access to thecoronary arteries.

FIG. 7 illustrates a leaflet-cutting procedure where a leaflet of anative aortic valve can be split at a location of an entrance to acoronary artery when a prosthetic heart valve is implanted within theaortic valve to enable increased blood flow to enter the coronaryartery.

FIG. 8A illustrates an exemplary prosthetic heart valve and an exampleof how splitting a native leaflet surrounding the prosthetic heart valveat a region of a frame of the prosthetic heart valve that is between twoadjacent commissures results in open cells in front of an entrance to acoronary artery.

FIG. 8B illustrates the exemplary prosthetic heart valve of FIG. 8A andhow splitting the native leaflet in a region of the frame of theprosthetic heart valve that includes a commissure does not result inopen cells being arranged in front of the entrance to the coronaryartery.

FIG. 9 is a side view of an embodiment of a delivery apparatusconfigured to deliver and implant a radially expandable prosthetic heartvalve at an implantation site.

FIG. 10 is a cross-sectional side view of a distal end portion of thedelivery apparatus of FIG. 9 .

FIG. 11 is a side view of the distal end portion of the deliveryapparatus of FIG. 9 , illustrating a distal tip portion of an outershaft of the delivery apparatus.

FIG. 12 is a schematic view of an embodiment of an intermediate shaft ofthe delivery apparatus of FIG. 9 .

FIG. 13 is a cross-sectional side view of a detail portion of coaxialshafts of the delivery apparatus of FIG. 11 .

FIG. 14 is a cross-sectional side view of a handle of the deliveryapparatus of FIG. 9 .

FIG. 15 is a first perspective view of an embodiment of a rotatable knobmounted on a proximal end portion of an intermediate shaft of a deliveryapparatus, the knob configured to rotate the intermediate shaft, therebyrotating an inflatable balloon and prosthetic heart valve radiallycompressed onto the balloon.

FIG. 16 is a second perspective view of the knob of FIG. 15 .

FIG. 17 is a cross-sectional side view of the knob of FIG. 15 .

FIG. 18 is a cross-sectional view of an anchor of the knob of FIG. 15 ,the anchor configured to couple the knob to the intermediate shaft.

FIG. 19 is a perspective view of the anchor of FIG. 18 .

FIG. 20 is an exploded view of an outer housing of the knob of FIG. 15 .

FIG. 21 is a side view of the anchor of FIG. 18 , mounted on theproximal end portion of the intermediate shaft.

FIG. 22 is a side view of the knob of FIG. 15 , mounted on the proximalend portion of the intermediate shaft with one housing portion of theouter housing removed to show the anchor.

FIG. 23 is a perspective view of an embodiment of a proximal end portionof a delivery apparatus, including a handle, rotatable knob, and anadaptor.

FIG. 24 is a perspective view of the adaptor in FIG. 23 , the adaptorcomprising a first port and a second port that is configured to rotaterelative to a body of the adaptor and the first port.

FIG. 25 is a cross-sectional view of the adaptor of FIG. 24 .

FIG. 26 is a cross-sectional view of the adaptor of FIG. 24 , mounted onthe proximal end portion of the delivery apparatus.

FIG. 27 is a detail, cross-sectional view of a portion of the adaptor ofFIG. 26 including a rotating interface between the second port and thebody of the adaptor.

FIG. 28 illustrates a side view of a distal end portion of a deliveryapparatus with an exemplary radiopaque marker positioned on and/orembedded within a polymeric body of the distal end portion of thedelivery apparatus.

FIG. 29 illustrates an exemplary fluoroscopic image of the distal endportion of the delivery apparatus, including the radiopaque marker, ofFIG. 28 .

FIG. 30 illustrates an embodiment of an asymmetric radiopaque markerthat allows a user to differentiate between two different positions ofthe marker within an imaging view.

FIG. 31A is an exemplary fluoroscopic image illustrating a guidewireextending through a distal end portion of a delivery apparatus and theasymmetric marker of FIG. 30 arranged on or embedded within a portion ofthe distal end portion of the delivery apparatus and in a firstorientation relative to the guidewire.

FIG. 31B is an exemplary fluoroscopic image illustrating a guidewireextending through a distal end portion of a delivery apparatus and theasymmetric marker of FIG. 30 arranged on or embedded within a portion ofthe distal end portion of the delivery apparatus and in a secondorientation relative to the guidewire.

FIG. 32A a side view of an exemplary delivery apparatus with theasymmetric marker of FIG. 30 arranged on or embedded within a distalshoulder of the delivery apparatus.

FIG. 32B is a perspective view of the exemplary delivery apparatus ofFIG. 32A with the asymmetric marker of FIG. 30 arranged on or embeddedwithin the distal shoulder of the delivery apparatus.

FIG. 33 illustrates another embodiment of an asymmetric radiopaquemarker that allows a user to differentiate between two differentpositions of the marker within an imaging view.

FIG. 34A is an exemplary fluoroscopic image illustrating a guidewireextending through a distal end portion of a delivery apparatus and theasymmetric marker of FIG. 33 arranged on or embedded within a portion ofthe distal end portion of the delivery apparatus and in a firstorientation relative to the guidewire.

FIG. 34B is an exemplary fluoroscopic image illustrating a guidewireextending through a distal end portion of a delivery apparatus and theasymmetric marker of FIG. 33 arranged on or embedded within a portion ofthe distal end portion of the delivery apparatus and in a secondorientation relative to the guidewire.

FIG. 35A illustrates an exemplary embodiment of a radiopaque markerattached to a commissure of a prosthetic valve, the prosthetic valve ina radially compressed configuration.

FIG. 35B illustrates the prosthetic valve of FIG. 35A in a radiallyexpanded configuration.

FIG. 35C illustrates an exemplary prosthetic heart valve with a firstattachment member arranged across a cell of the prosthetic heart valveand secured to struts forming the cell, and a radiopaque marker securedto a second attachment member that is configured to be attached to thestruts forming the cell, where commissure tabs of adjacent leaflets ofthe prosthetic heart valve are secured to the first attachment member toform a commissure

FIGS. 35D-35F illustrate the first attachment member and the secondattachment member being attached to the struts forming the cell at thesame time with the same sutures.

FIG. 35G illustrates the marker of FIG. 35C, attached to the secondattachment member that is attached to the struts forming the cell of theprosthetic valve, in front of the first attachment member of thecommissure.

FIG. 35H illustrates an inner surface of the commissure and the firstattachment member attached to the cell of the prosthetic valve.

FIG. 35I illustrates an exemplary radiopaque marker configured to beattached to a commissure within a cell of a prosthetic valve.

FIG. 35J illustrates another exemplary embodiment of a radiopaque markerattached to a commissure within a cell of a prosthetic valve.

FIG. 35K illustrates another exemplary embodiment of a radiopaque markerattached to a commissure within a cell of a prosthetic valve.

FIG. 35L illustrates another exemplary embodiment of a radiopaque markerattached to a commissure within a cell of a prosthetic valve and aradiopaque marker attached to a skirt extending across an inner surfaceof a frame of the prosthetic valve, directly below the commissure.

FIG. 35M illustrates another exemplary embodiment of a radiopaque markerattached to a commissure within a cell of a prosthetic valve, theprosthetic valve in a radially compressed configuration.

FIG. 35N illustrates another exemplary embodiment of a radiopaque markerattached to a commissure within a cell of a prosthetic valve, theprosthetic valve in a radially compressed configuration.

FIG. 35O illustrates an exemplary embodiment of a radiopaque markerattached to a first attachment member, the first attachment memberattached to a second attachment member of a commissure within a cell ofa prosthetic valve.

FIG. 35P illustrates another exemplary embodiment of a radiopaque markerattached to a first attachment member, the first attachment memberattached to a second attachment member of a commissure within a cell ofa prosthetic valve.

FIG. 36 illustrates an embodiment of an inflatable balloon folded arounda distal end portion of a delivery apparatus.

FIG. 37 is a cross-sectional view of an inflatable balloon wrapped andfolded around a portion of a delivery apparatus, at a valve mountingportion of the delivery apparatus, according to an embodiment.

FIG. 38 is a perspective view of an embodiment of a distal tip portionfor an outer shaft of a delivery apparatus including a plurality ofhelical internal expansion grooves.

FIG. 39 is a cross-sectional view of the distal tip portion of FIG. 38mounted on a distal end of the outer shaft and arranged over a portionof an inflatable balloon of the delivery apparatus.

FIG. 40 is a side view of a distal end portion of delivery apparatusillustrating a radial depression in a distal end portion of aninflatable balloon of the delivery apparatus, when the distal tipportion is arranged away from a proximal end portion of the balloon.

FIG. 41 is a side view of the distal end portion of the deliveryapparatus of FIG. 40 , illustrating a state of the distal end portion ofthe inflatable balloon when the distal tip portion is arranged over theproximal end portion of the balloon and a prosthetic valve is mounted ona valve mounting portion of the delivery apparatus.

FIG. 42 is a side view of a distal end portion of an exemplary deliveryapparatus with a prosthetic valve mounted on and around a valve mountingportion of the distal end portion of the delivery apparatus, in aradially compressed state, with a selected commissure of the prostheticvalve circumferentially offset from a radiopaque marker on the deliveryapparatus by a predetermined amount.

FIG. 43 is a rear perspective view of an exemplary embodiment of acrimping device configured to crimp a prosthetic valve onto a portion ofa delivery apparatus.

FIG. 44 is a front perspective view of the crimping device of FIG. 43 .

FIG. 45 is a perspective view of an embodiment of a support body for amounting assembly configured to mount and crimp a prosthetic valve ontoa delivery apparatus at a predetermined position and/or orientationrelative to the delivery apparatus, the support body configured to holdthe prosthetic valve in a radially expanded state.

FIG. 46 is a front perspective view of an embodiment of a ring bodyconfigured to couple to the support body of FIG. 45 andcircumferentially align the prosthetic valve on the support body in adesired orientation.

FIG. 47 is a rear perspective view of the ring body of FIG. 46 .

FIG. 48 is a perspective view of the ring body of FIG. 46 coupled withthe support body of FIG. 45 .

FIG. 49 is a perspective view of an embodiment of a positioning deviceof a mounting assembly, coupled to a distal end portion of a deliveryapparatus.

FIG. 50 is an end view of a prosthetic valve mounted on the support bodyof FIG. 45 , with commissure aligned with corresponding indicators onthe ring body of FIG. 46 .

FIG. 51 is a cross-sectional view of the mounting assembly, includingthe support body of FIG. 45 and the positioning device of FIG. 49 ,coupled to and arranged within the crimping device of FIG. 43 such thatthe prosthetic valve is arranged in a predetermined orientation and/orposition around a valve mounting portion of a distal end portion of thedelivery apparatus, relative to the delivery apparatus.

FIG. 52 is a cross-sectional view of the prosthetic valve radiallycompressed onto the valve mounting portion of the delivery apparatus,after performing a crimping operation with the crimping device of FIG.43 .

FIG. 53 is a perspective view of another embodiment of a positioningdevice that can be used in a mounting assembly and coupled to a crimpingdevice.

FIG. 54 is a side view of the positioning device of FIG. 53 coupled to adistal end portion of a delivery apparatus, proximal to a valve mountingportion.

FIG. 55 is a perspective view of the positioning device of FIG. 53coupled to the distal end portion of the delivery apparatus of FIG. 54 .

FIG. 56 is a flow chart of an exemplary method for crimping a prostheticvalve into a radially compressed state onto a distal end portion of adelivery apparatus, in a predetermined position and in a predeterminedorientation relative to the delivery apparatus.

FIG. 57 is a flow chart of an exemplary method for implanting aprosthetic valve at a native valve of a patient with one or moreselected commissures of the prosthetic valve in alignment with one ormore corresponding commissures of the native valve.

FIG. 58 illustrates an exemplary fluoroscopic image of a native valveviewed with a standard, three-cusp imaging view.

FIG. 59 illustrates an exemplary fluoroscopic image of a distal endportion of a delivery apparatus including an asymmetric radiopaquemarker, where the marker is centered along a guidewire extending throughthe delivery apparatus and appears in a forward-readable orientation,thereby indicating the marker is in a direct back of the imaging view.

FIG. 60 is a schematic illustrating a desired rotational positioning ofa distal end portion of a delivery apparatus, including a prostheticvalve mounted thereon, at a native valve with an asymmetric radiopaquemarker of the delivery apparatus aligned with a target commissure of thenative valve and a selected commissure of the prosthetic valvecircumferentially offset from the marker by a predetermined amount.

FIG. 61 is a schematic of an embodiment of a three-cusp imaging view ofa native valve which can be used for visualizing a delivery apparatus ina patient's heart during an implantation procedure and rotationallyaligning a prosthetic valve mounted on the delivery apparatus.

FIG. 62 is a cross-sectional view of a native valve, illustrating alocation of commissures of the native valve within the imaging view ofFIG. 61 .

FIG. 63 is a schematic of an embodiment of a right/left cusp overlapimaging view of a native valve which can be used for visualizing adelivery apparatus in a patient's heart during an implantation procedureand rotationally aligning a prosthetic valve mounted on the deliveryapparatus.

FIG. 64 is a cross-sectional view of a native valve, illustrating alocation of commissures of the native valve within the imaging view ofFIG. 63 .

FIG. 65 illustrates an embodiment of an alignment ring configured torotationally align a prosthetic valve relative to a delivery apparatusfor an implantation procedure using a first imaging view.

FIG. 66 illustrates another embodiment of an alignment ring configuredto rotationally align a prosthetic valve relative to a deliveryapparatus for an implantation procedure using a second imaging view.

FIG. 67 illustrates another embodiment of an alignment ring includingmultiple sets of alignment markers for use in two or more implantationprocedures utilizing differently selected imaging views.

FIG. 68 illustrates another embodiment of an alignment ring includingone or more sets of graduated alignment markers.

FIG. 69 is an exploded view of an embodiment of a balloon cover for adistal end portion of delivery apparatus which is configured to cover aninflatable balloon and a positioning device mounted on the distal endportion.

FIG. 70 is a perspective view of a shell member of the balloon cover ofFIG. 60 , the shell member configured to matingly engage with anothershell member of the balloon cover to form an outer shell of the ballooncover.

FIG. 71A is a detail view of a portion of a mating edge of the shellmember of FIG. 70 which includes an elongate protrusion.

FIG. 71B is a detail view of another portion of the mating edge of theshell member of FIG. 70 which includes an elongate groove.

FIG. 71C is a detail view of a portion of a mating interface between twoshell members of the balloon cover of FIG. 60 , when in an assembledconfiguration where the mating edges of the two shell members areengaged with one another.

FIG. 72 is a first side view of the balloon cover of FIG. 69 in anassembled configuration and with components arranged inside and coveredby the balloon cover being shown with dashed lines.

FIG. 73 is a second side view of the balloon cover of FIG. 69 in anassembled configuration, wherein the second side view is rotated fromthe first side view of FIG. 72 .

FIG. 74 is a perspective end view of the balloon cover of FIG. 69 , froma proximal end of the balloon cover, in an assembled configuration.

FIG. 75A is a perspective view of the balloon cover of FIG. 69 in anassembled configuration, where the portion of the balloon cover coveringthe positioning device has walls including one or more windows that areconfigured to reduce a height of the balloon cover.

FIG. 75B is an end view of the balloon cover of FIG. 75A.

FIG. 75C is a cross-sectional end view of the balloon cover of FIG. 75A.

FIG. 76A is a perspective view of another embodiment of a balloon coverfor a distal end portion of delivery apparatus which is configured tocover an inflatable balloon and a positioning device mounted on thedistal end portion, where a portion of the balloon cover covering thepositioning device has walls that fully enclose the positioning devicetherein.

FIG. 76B is an end view of the balloon cover of FIG. 76A.

FIG. 77 is an exploded view of another embodiment of a balloon cover fora distal end portion of delivery apparatus which is configured to coveran inflatable balloon and a positioning device mounted on the distal endportion and create a specified, final shape of the inflatable balloon.

FIG. 78 is a perspective view of a depression sleeve of the ballooncover of FIG. 77 , the depression sleeve including one or moredepression members.

FIG. 79 is an end view of the depression sleeve of FIG. 78 .

FIG. 80 is another perspective view of the depression sleeve of FIG. 78.

FIG. 81A is a cross-sectional side view of the depression sleeve of FIG.78 in an unflexed or resting configuration.

FIG. 81B is a cross-sectional side view of the depression sleeve of FIG.78 in a flexed or radially inward configuration.

FIG. 82 is a perspective view of a shell member of the balloon cover ofFIG. 77 disassembled from a remainder of the balloon cover.

FIG. 83A is a first cross-sectional side view of the assembled ballooncover of FIG. 77 .

FIG. 83B is a second cross-sectional side view of the assembled ballooncover of FIG. 77 .

FIG. 84 is a plan view of another exemplary embodiment of a shell memberfor a balloon cover that is configured to receive a portion of a distalend portion of a delivery apparatus that includes an inflatable balloonand a positioning device mounted thereon and form a specified, finalshape of the balloon around the delivery apparatus.

FIG. 85 is a perspective view of the shell member of FIG. 84 .

FIG. 86 is a cross-sectional side view of the shell member of FIG. 84 .

FIG. 87A is a perspective view of a shaft connector release assemblycoupling a proximal end portion of a rotatable shaft of a deliveryapparatus to an adaptor.

FIG. 87B is a cross-sectional view of the shaft connector releaseassembly of FIG. 87A coupling the proximal end portion of the rotatableshaft to the adaptor.

FIG. 88 is an exploded view of the shaft connector release assembly,proximal end portion of the rotatable shaft, and the adaptor of FIG.87A.

FIG. 89 is a perspective view of the shaft connector release assembly ofFIG. 87A, alone, in an assembled configuration.

FIG. 90 is an exploded view of the shaft connector release assembly ofFIG. 89 .

FIG. 91 is a perspective view of an embodiment of a release sleeve ofthe shaft connector release sleeve of FIG. 89 .

FIG. 92 is a side view of the release sleeve of FIG. 91 .

FIG. 93 is a cross-sectional side view of the release sleeve of FIG. 92.

FIG. 94 is a perspective view of an embodiment of an adaptor insert ofthe shaft connector release assembly of FIG. 89 .

FIG. 95 is a side view of the adaptor insert of FIG. 94 .

FIG. 96 is a cross-sectional side view of the adaptor insert of FIG. 95.

FIG. 97 shows an exemplary radiopaque marker sewn to a central portionof an attachment member, the attachment member configured to form acommissure with commissure tabs of adjacent leaflets of the prostheticheart valve and configured to be arranged across a cell of a prostheticheart valve and secured to struts forming the cell.

FIG. 98A shows the marker secured to an outer surface of the attachmentmember of FIG. 97 and the commissure tabs secured to an inner surface ofthe attachment member.

FIG. 99B shows the attachment member of FIG. 98A attached to the strutsof the cell and the marker facing away from the commissure.

FIG. 99A shows the marker secured to an inner surface of the attachmentmember of FIG. 97 and the commissure tabs secured to an inner surface ofthe attachment member.

FIG. 99B shows the attachment member of FIG. 99B attached to the strutsof the cell and the marker facing toward the commissure.

FIG. 100 shows an exemplary embodiment of a marker positioned against anelongate flap of an attachment member, the attachment member configuredto form a commissure with commissure tabs of adjacent leaflets of theprosthetic heart valve and configured to be arranged across a cell of aprosthetic heart valve and secured to struts forming the cell.

FIGS. 101A-101E show a process for sewing the marker to the attachmentmember of FIG. 100 using one or more fasteners used to secure thecommissure tabs of the leaflets to the attachment member.

FIG. 102 is a perspective view of another embodiment of a rotatable knobmounted on a proximal end portion of an intermediate shaft of a deliveryapparatus, the knob configured to rotate the intermediate shaft, therebyrotating an inflatable balloon and prosthetic heart valve radiallycompressed onto the balloon.

FIG. 103 is a side view of the knob of FIG. 102 .

FIG. 104 is a first exploded view of the know of FIG. 102 that shows twohousing portions of the knob which enclose an anchor and adaptortherein.

FIG. 105 is a second exploded view of the knob of FIG. 102 .

FIG. 106 is a first cross-sectional side view of the knob of FIG. 102that shows the anchor and adaptor inside the housing of the knob.

FIG. 107 is a second cross-sectional side view of the knob of FIG. 102that shows an aligning tab of the anchor and the adaptor inside thehousing of the knob.

FIG. 108 is a perspective view of another embodiment of a balloon coverfor a distal end portion of delivery apparatus which is configured tocover an inflatable balloon and a positioning device mounted on thedistal end portion.

FIG. 109 is a side view of the balloon cover of FIG. 108 .

FIG. 110 is an exploded view of the balloon cover of FIG. 108 .

FIG. 111 is another side view of the balloon cover of FIG. 108 thatshows a sleeve covering a portion of the balloon cover that includes aviewing window for an underlying radiopaque marker on the distal endportion of the delivery apparatus.

FIG. 112 is another side view of the balloon cover of FIG. 111 with thesleeve removed such that the viewing window and the underlyingradiopaque marker on the distal end portion of the delivery apparatusare visible.

FIG. 113 is a cross-sectional perspective view of the balloon cover ofFIG. 108 .

FIG. 114 is a partial cross-sectional side view of the balloon cover ofFIG. 108 .

DETAILED DESCRIPTION General Considerations

For purposes of this description, certain aspects, advantages, and novelfeatures of the embodiments of this disclosure are described herein. Thedescribed methods, systems, and apparatus should not be construed aslimiting in any way. Instead, the present disclosure is directed towardall novel and non-obvious features and aspects of the various disclosedembodiments, alone and in various combinations and sub-combinations withone another. The disclosed methods, systems, and apparatus are notlimited to any specific aspect, feature, or combination thereof, nor dothe disclosed methods, systems, and apparatus require that any one ormore specific advantages be present, or problems be solved.

Features, integers, characteristics, compounds, chemical moieties, orgroups described in conjunction with a particular aspect, embodiment orexample of the disclosure are to be understood to be applicable to anyother aspect, embodiment or example described herein unless incompatibletherewith. All of the features disclosed in this specification(including any accompanying claims, abstract, and drawings), and/or allof the steps of any method or process so disclosed, may be combined inany combination, except combinations where at least some of suchfeatures and/or steps are mutually exclusive. The disclosure is notrestricted to the details of any foregoing embodiments. The disclosureextends to any novel one, or any novel combination, of the featuresdisclosed in this specification (including any accompanying claims,abstract, and drawings), or to any novel one, or any novel combination,of the steps of any method or process so disclosed.

Although the operations of some of the disclosed methods are describedin a particular, sequential order for convenient presentation, it shouldbe understood that this manner of description encompasses rearrangement,unless a particular ordering is required by specific language set forthbelow. For example, operations described sequentially may in some casesbe rearranged or performed concurrently. Moreover, for the sake ofsimplicity, the attached figures may not show the various ways in whichthe disclosed methods, systems, and apparatus can be used in conjunctionwith other systems, methods, and apparatus.

As used herein, the terms “a,” “an,” and “at least one” encompass one ormore of the specified element. That is, if two of a particular elementare present, one of these elements is also present and thus “an” elementis present. The terms “a plurality of” and “plural” mean two or more ofthe specified element.

As used herein, the term “and/or” used between the last two of a list ofelements means any one or more of the listed elements. For example, thephrase “A, B, and/or C” means “A,” “B,” “C,” “A and B,” “A and C,” “Band C,” or “A, B, and C.”

As used herein, the term “coupled” generally means physically coupled orlinked and does not exclude the presence of intermediate elementsbetween the coupled items absent specific contrary language.

Directions and other relative references (e.g., inner, outer, upper,lower, etc.) may be used to facilitate discussion of the drawings andprinciples herein, but are not intended to be limiting. For example,certain terms may be used such as “inside,” “outside,”, “top,” “down,”“interior,” “exterior,” and the like. Such terms are used, whereapplicable, to provide some clarity of description when dealing withrelative relationships, particularly with respect to the illustratedembodiments. Such terms are not, however, intended to imply absoluterelationships, positions, and/or orientations. For example, with respectto an object, an “upper” part can become a “lower” part simply byturning the object over. Nevertheless, it is still the same part and theobject remains the same. As used herein, “and/or” means “and” or “or,”as well as “and” and “or.”

As used herein, with reference to the prosthetic heart valve and thedelivery apparatus, “proximal” refers to a position, direction, orportion of a component that is closer to the user and/or a handle of thedelivery apparatus that is outside the patient, while “distal” refers toa position, direction, or portion of a component that is further awayfrom the user and/or the handle of the delivery apparatus and closer tothe implantation site. The terms “longitudinal” and “axial” refer to anaxis extending in the proximal and distal directions, unless otherwiseexpressly defined. Further, the term “radial” refers to a direction thatis arranged perpendicular to the axis and points along a radius from acenter of an object (where the axis is positioned at the center, such asthe longitudinal axis of the prosthetic valve).

EXAMPLES OF THE DISCLOSED TECHNOLOGY

Described herein are examples of prosthetic valve delivery apparatusesand methods for delivering and implanting a radially expandableprosthetic valve at a native valve of a heart such that commissures ofthe prosthetic valve are circumferentially aligned within commissures ofthe native valve.

Also described herein are examples of balloon covers configured toreceive a distal end portion of a delivery apparatus therein. In someembodiments, such balloon covers can be configured to create a specifiedshape of an inflatable balloon overlying a portion of the distal endportion of the delivery apparatus.

Also described herein are assemblies for coupling a rotatable shaft ofthe delivery apparatus to an adaptor of the delivery apparatus that isconfigured to receive inflation fluid for the inflatable balloon of thedelivery apparatus.

In some embodiments, a delivery apparatus can include a first shaft thatis configured to rotate around a central longitudinal axis of thedelivery apparatus to rotationally align a prosthetic valve mounted onthe delivery apparatus with native anatomy at a target implantationsite. The delivery apparatus can further include a second shaftextending through the first shaft and having a distal end portionextending distally beyond a distal end portion of the first shaft.

In some embodiments one or more polymeric bodies, such as one or moreballoon shoulders and/or a nose cone can be mounted on the distal endportion of the second shaft. The delivery apparatus can further includean inflatable balloon coupled to the distal end portion of the firstshaft. In some embodiments, a shoulder, or another polymeric body of thedelivery apparatus, can be arranged within the balloon and a radiopaquemarker can be mounted on or embedded within the shoulder at a locationspaced radially outward from an outer surface of the distal end portionof the second shaft. The marker can be reflection asymmetric along anaxis that is parallel to the central longitudinal axis of the deliveryapparatus. The shoulder can be configured such that when the prostheticvalve is mounted on the balloon in a radially compressed state, theshoulder resists movement of the prosthetic valve relative to theballoon in an axial direction.

In this way, the delivery apparatus can be configured to rotationallyalign the radially compressed prosthetic valve at the native valve suchthat prosthetic valve is implanted with commissures of the prostheticvalve in alignment (e.g., circumferential alignment) with commissures ofthe native valve. For example, rotating the first shaft can result inrotation of the balloon and the radially compressed prosthetic valvemounted thereon. In some embodiments, the first shaft can be rotated ator proximate to the native valve until the marker on the shoulder oralternate polymeric body of the delivery apparatus is aligned with adesired landmark of the native anatomy and/or a guidewire, within aselected imaging view.

Prosthetic valves disclosed herein can be radially compressible andexpandable between a radially compressed configuration and a radiallyexpanded configuration. Thus, the prosthetic valves can be crimped on adelivery apparatus in the radially compressed configuration duringdelivery, and then expanded to the radially expanded configuration oncethe prosthetic valve reaches the implantation site. In some embodiments,the prosthetic valve can be deployed from the delivery apparatus at theimplantation site (e.g., a native valve of a heart) via inflating aninflatable balloon of the delivery apparatus.

FIG. 1 shows a prosthetic heart valve (e.g., prosthetic valve) 10,according to one embodiment. The illustrated prosthetic valve is adaptedto be implanted in the native aortic annulus, although in otherembodiments it can be adapted to be implanted in the other nativeannuluses of the heart (e.g., the pulmonary, mitral, and tricuspidvalves). The prosthetic valve can also be adapted to be implanted inother tubular organs or passageways in the body. The prosthetic valve 10can have four main components: a stent or frame 12, a valvular structure14, an inner skirt 16, and a perivalvular outer sealing member or outerskirt 18. The prosthetic valve 10 can have an inflow end portion 15, anintermediate portion 17, and an outflow end portion 19.

The valvular structure 14 can comprise three leaflets 40, collectivelyforming a leaflet structure, which can be arranged to collapse in atricuspid arrangement, although in other embodiments there can begreater or fewer number of leaflets (e.g., one or more leaflets 40). Theleaflets 40 can be secured to one another at their adjacent sides toform commissures 22 of the valvular (e.g., leaflet) structure 14. Thelower edge of valvular structure 14 can have an undulating, curvedscalloped shape and can be secured to the inner skirt 16 by sutures (notshown). In some embodiments, the leaflets 40 can be formed ofpericardial tissue (e.g., bovine pericardial tissue), biocompatiblesynthetic materials, or various other suitable natural or syntheticmaterials as known in the art and described in U.S. Pat. No. 6,730,118,which is incorporated by reference herein.

The frame 12 can be formed with a plurality of circumferentially spacedslots, or commissure windows 20 that are adapted to mount thecommissures 22 of the valvular structure 14 to the frame. The frame 12can be made of any of various suitable plastically-expandable materials(e.g., stainless steel, etc.) or self-expanding materials (e.g., nickeltitanium alloy (NiTi), such as nitinol), as known in the art. Whenconstructed of a plastically-expandable material, the frame 12 (and thusthe prosthetic valve 10) can be crimped to a radially collapsedconfiguration on a delivery catheter and then expanded inside a patientby an inflatable balloon or equivalent expansion mechanism. Whenconstructed of a self-expandable material, the frame 12 (and thus theprosthetic valve 10) can be crimped to a radially collapsedconfiguration and restrained in the collapsed configuration by insertioninto a sheath or equivalent mechanism of a delivery catheter.

Once inside the body, the prosthetic valve can be advanced from thedelivery sheath, which allows the prosthetic valve to expand to itsfunctional size.

Suitable plastically-expandable materials that can be used to form theframe 12 include, without limitation, stainless steel, a biocompatible,high-strength alloys (e.g., a cobalt-chromium or anickel-cobalt-chromium alloys), polymers, or combinations thereof. Inparticular embodiments, frame 12 is made of anickel-cobalt-chromium-molybdenum alloy, such as MP35N® alloy (SPSTechnologies, Jenkintown, Pa.), which is equivalent to UNS R30035 alloy(covered by ASTM F562-02). MP35N® alloy/UNS R30035 alloy comprises 35%nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight.Additional details regarding the prosthetic valve 10 and its variouscomponents are described in WIPO Patent Application Publication No. WO2018/222799, which is incorporated herein by reference.

FIG. 2A is a perspective view of a prosthetic heart valve 50, accordingto another embodiment. The prosthetic valve 50 can have three maincomponents: a stent or frame, 52, a valvular structure 54, and a sealingmember 56. FIG. 2B is a perspective view of the prosthetic valve 50 withthe components on the outside of the frame 52 (including the sealingmember 56) shown in transparent lines for purposes of illustration.

Like the valvular structure 14 of FIG. 1 , the valvular structure 54 cancomprise three leaflets 60, collectively forming a leaflet structure,which can be arranged to collapse in a tricuspid arrangement. Eachleaflet 60 can be coupled to the frame 52 along its inflow edge 62 (thelower edge in the figures; also referred to as “cusp edges”) and atcommissures 64 of the valvular structure 54 where adjacent portions(e.g., commissure tabs) of two leaflets are connected to each other. Insome embodiments, the commissures 64 can comprise an attachment member(e.g., comprising fabric, flexible polymer, or the like) arranged acrossa cell (e.g., commissure cell) of the frame 52, the cell formed bystruts of the frame. The attachment member can be secured to the strutsof the frame forming the cell and the adjacent portions of the twoleaflets can be connected to the attachment member to form thecommissure 64 (e.g., as shown in FIGS. 16 and 17 , as described furtherbelow).

A reinforcing element (not shown), such as a fabric strip, can beconnected directly to the cusp edges of the leaflets and to the strutsof the frame to couple the cusp edges of the leaflets to the frame.

Similar to the frame 12 of FIG. 1 , the frame 52 can be made of any ofvarious suitable plastically-expandable materials or self-expandingmaterials, as known in the art and described above. The frame 52 in theillustrated embodiment comprises a plurality of circumferentiallyextending rows of angled struts 72 defining rows of cells, or openings,74 of the frame. The frame 52 can have a cylindrical or substantiallycylindrical shape having a constant diameter from an inflow end 66 to anoutflow end 68 of the frame as shown, or the frame can vary in diameteralong the height of the frame, as disclosed in U.S. Patent PublicationNo. 2012/0239142, which is incorporated herein by reference.

The frame 52, at each of the inflow end 66 and the outflow end 68, maycomprise a plurality of apices 80 spaced apart from one another around acircumference of the frame 52.

The sealing member 56 in the illustrated embodiment is mounted on theoutside of the frame 52 and functions to create a seal against thesurrounding tissue (e.g., the native leaflets and/or native annulus) toprevent or at least minimize paravalvular leakage. The sealing member 56can comprise an inner layer 76 (which can be in contact with the outersurface of the frame 52) and an outer layer 78. The sealing member 56can be connected to the frame 52 using suitable techniques ormechanisms. For example, the sealing member 56 can be sutured to theframe 52 via sutures that can extend around the struts 72 and throughthe inner layer 76. In alternative embodiments, the inner layer 76 canbe mounted on the inner surface of the frame 52, while the outer layer78 is on the outside of the frame 52.

The outer layer 78 can be configured or shaped to extend radiallyoutward from the inner layer 76 and the frame 52 when the prostheticvalve 50 is deployed. When the prosthetic valve is fully expandedoutside of a patient's body, the outer layer 78 can expand away from theinner layer 76 to create a space between the two layers. Thus, whenimplanted inside the body, this allows the outer layer 78 to expand intocontact with the surrounding tissue.

Additional details regarding the prosthetic valve 50 and its variouscomponents are described in U.S. Patent Publication No. 2018/0028310,which is incorporated herein by reference.

FIG. 3 shows a delivery device (e.g., apparatus) 100, according to anembodiment, that can be used to implant an expandable prosthetic heartvalve (e.g., prosthetic valve 10 or 50), or another type of expandableprosthetic medical device (such as a stent). In some embodiments, thedelivery device 100 is specifically adapted for use in introducing aprosthetic valve into a heart.

The delivery device 100 in the illustrated embodiment of FIG. 3 is aballoon catheter comprising a handle 102, a steerable, outer shaft 104extending from the handle 102, an intermediate shaft extending from thehandle 102 coaxially through the steerable outer shaft 104, and an innershaft 106 extending from the handle 102 coaxially through theintermediate shaft and the steerable, outer shaft 104, an inflatableballoon (e.g., balloon) 108 extending from a distal end of theintermediate shaft, and a nosecone 110 arranged at a distal end of thedelivery device 100. A distal end portion 112 of the delivery device 100includes the balloon 108, the nosecone 110, and a balloon shoulderassembly. A prosthetic medical device, such as a prosthetic heart valvemay be mounted on a valve retaining portion of the balloon 108, asdescribed further below with reference to FIGS. 9-11, 41, and 42 . Asdescribed further below, the balloon shoulder assembly is configured tomaintain the prosthetic heart valve or other medical device at a fixedposition on the balloon 108 during delivery through the patient'svasculature. In some embodiments, the balloon shoulder assembly caninclude a proximal shoulder 120 and/or a distal shoulder 122.

The handle 102 can include a steering mechanism configured to adjust thecurvature of the distal end portion of the delivery device. In theillustrated embodiment, for example, the handle 102 includes anadjustment member, such as the illustrated rotatable knob 134, which inturn is operatively coupled to the proximal end portion of a pull wire(not shown). The pull wire extends distally from the handle 102 throughthe outer shaft 104 and has a distal end portion affixed to the outershaft at or near the distal end of the outer shaft 104. Rotating theknob 134 is effective to increase or decrease the tension in the pullwire, thereby adjusting the curvature of the distal end portion of thedelivery device.

In some embodiments, the delivery apparatus (or another, similardelivery apparatus) can be configured to deploy and implant a prostheticheart valve (e.g., prosthetic valve 10 of FIG. 1 or prosthetic heartvalve 50 of FIGS. 2A and 2B) in the native aortic annulus of a nativeaortic valve. An exemplary heart 200 including an aortic valve 202 isshown in FIG. 4 . As shown in FIG. 4 , two coronary arteries (e.g., theleft coronary artery and the right coronary artery) 204 are coupled toand branch off from the aorta 205, proximate to the aortic valve 202.The coronary arteries 204 carry oxygenated blood from the aorta to themuscle of the heart 200.

As shown in FIG. 5A, since the prosthetic heart valve 206 is implantedin the native aortic annulus of the aortic valve 202, blood flow 208 mayexit the prosthetic heart valve 206, flow into the aorta 205, and thenflow over top of the outflow end of the prosthetic heart valve 206and/or through open cells (e.g., open cells that are not constantlycovered by leaflets of the prosthetic heart valve) in the frame of theprosthetic heart valve 206, to the coronary artery 204 (only one shownin FIGS. 5A and 5B). Depending on a patient's anatomy, the prostheticheart valve may cover (e.g., be placed in front of) at least a portionof the opening to the coronary artery 204, as shown in the exampledepicted in FIG. 5B. The interference with blood flow to the coronaryarteries 204 can be further exacerbated when a commissure 210 of theprosthetic heart valve 206 is arranged in front of (e.g., adjacent to)an opening to one of the coronary arteries 204 (FIG. 5B). For example,since adjacent leaflets are coupled together at the commissures 210, thecommissures 210 block and/or reduce blood flow through the cells towhich they are coupled. Thus, less oxygenated blood flow can reach thecoronary arteries and the heart muscle.

Thus, instead of deploying the prosthetic heart valve with the deliveryapparatus in a random rotational orientation relative to the aorta 205,which may result in commissures 210 of the prosthetic heart valve 206being arranged in front of the coronary arteries 204 (as shown in FIG.6A), it may be desirable to deploy the prosthetic heart valve 206 in antargeted rotational orientation where the commissures 210 are positionedaway from and do not block the coronary arteries 204 (as shown in FIG.6B). For example, as shown in FIG. 6B, the delivery apparatus can beconfigured to deploy the prosthetic heart valve 206 such thatcommissures 210 of the radially expanded prosthetic heart valve 206 arecircumferentially aligned with the native commissures 212 of the aorticvalve 202.

As explained further below, the delivery apparatus can be configured tocontrol the rotational positioning of the prosthetic heart valve 206relative to the native valve, to achieve the commissure alignment shownin the example of FIG. 6B, thereby increasing blood flow access to thecoronary arteries 204. Additionally, this positioning of the prostheticheart valve can facilitate a later, leaflet cutting procedure thatprovides increased blood flow to the coronary arteries, as shown inFIGS. 7-8B.

For example, as shown in FIG. 7 , a native leaflet 214 of the nativevalve (e.g., aortic valve 202) can be split (e.g., cut) longitudinally(relative to a central longitudinal axis of the prosthetic heart valve206) at a location of an entrance to a coronary artery 204. This enablesincreased blood flow to enter the coronary artery 204 from the aorta,through one or more open (e.g., not covered by leaflets) cells 216 ofthe prosthetic heart valve 206.

As shown in FIG. 8A, splitting a native leaflet 214 (shown surroundingthe prosthetic heart valve 206 in FIGS. 8A and 8B) at a region of aframe of the prosthetic heart valve 206 that is between two adjacentcommissures 210 results in open cells 216 that can receive blood flowtherethrough. However, as shown in FIG. 8B, splitting the native leaflet214 in a region of the frame of the prosthetic heart valve 206 thatincludes the commissure 210 (e.g., due to the commissure 210 beingpositioned in front of the entrance to the coronary artery 204), doesnot result in open cells 216 being arranged in front of the entrance tothe coronary artery 204.

Instead, the commissure 210 can continue to block blood flow to thecoronary artery 204.

Thus, it is desirable to have delivery apparatuses and methods fordeploying radially expandable prosthetic heart valves in a desiredrotational orientation relative to the native valve, such thatprosthetic heat valve commissures are in alignment with the native valvecommissures.

FIGS. 9-68 show embodiments of delivery apparatuses, methods, andrelated components, for implanting a radially expandable prostheticheart valve in a native valve with a delivery apparatus such thatcommissures of the prosthetic heart valve are aligned with commissuresof the native valve. In some embodiments, the prosthetic valve anddelivery apparatuses are configured such that the prosthetic valve isdeployed from the delivery apparatus at the native valve via inflating aballoon of the delivery apparatus.

FIGS. 9-14 show a delivery apparatus 300, according to an embodiment,that can be used to implant an expandable prosthetic heart valve (e.g.,prosthetic valve 10 of FIG. 1 or prosthetic valve 50 of FIGS. 2A-2B), oranother type of expandable prosthetic medical device (such as a stent).In some embodiments, the delivery apparatus 300 is specifically adaptedfor use in introducing a prosthetic valve into a heart. As describedfurther below, the delivery apparatus 300 can be configured to rotatethe prosthetic valve, mounted on the delivery apparatus in a radiallycompressed state, at the target implantation site (e.g., at a nativevalve of the heart) to achieve commissure alignment between the nativevalve and prosthetic valve after deploying the prosthetic valve.

Similar to the delivery device 100 of FIG. 3 , the delivery apparatus300 is a balloon catheter comprising a handle 302 and a steerable, outershaft 304 extending distally from the handle 302 (FIGS. 9 and 14 ). Thedelivery apparatus 300 can further comprise an intermediate shaft 306(which also may be referred to as a balloon shaft) that extendsproximally from the handle 302 (FIGS. 9 and 14 ) and distally from thehandle 302, the portion extending distally from the handle 302 alsoextending coaxially through the outer shaft 304. Additionally, thedelivery apparatus 300 can further comprise an inner shaft 308 extendingdistally from the handle 302 coaxially through the intermediate shaft306 and the outer shaft 304 (as show in the detail portion 355 in FIG.13 ) and proximally from the handle 302 coaxially through theintermediate shaft 306.

As described further below, the outer shaft 304 and the intermediateshaft 306 are configured to translate (e.g., move) longitudinally, alongthe central longitudinal axis 320, relative to one another to facilitatedelivery and positioning of a prosthetic valve at an implantation sitein a patient's body.

The intermediate shaft 306 can include a proximal end portion 310 thatextends proximally from a proximal end of the handle 302, to an adaptor312 (FIGS. 9 and 14 ). A rotatable knob 314 can be mounted on theproximal end portion 310 (FIGS. 9 and 14 ) and can be configured torotate the intermediate shaft 306 around a central longitudinal axis 320of the delivery apparatus 300 and relative to the outer shaft 304, asdescribed further below with reference to FIGS. 15-22 .

The adaptor 312 can include a first port 338 configured to receive aguidewire therethrough and a second port 340 configured to receive fluid(e.g., inflation fluid) from a fluid source. The second port 340 can befluidly coupled to an inner lumen of the intermediate shaft 306, asdescribed further below.

The intermediate shaft 306 can further include a distal end portion 316that extends distally beyond a distal end of the outer shaft 304 (FIGS.10 and 11 ) when a distal end of the outer shaft 304 is positioned awayfrom an inflatable balloon 318 of the delivery apparatus (e.g., asdescribed further below with reference to FIGS. 38-41 ). A distal endportion of the inner shaft 308 can extend distally beyond the distal endportion 316 of the intermediate shaft 306 (FIG. 10 ).

The balloon 318 is coupled to the distal end portion 316 of theintermediate shaft 306. For example, in some embodiments, a proximal endportion of the balloon 318 is coupled to and/or around a distal end 348of the intermediate shaft 306 (FIGS. 10 and 11 ).

The balloon 318 can comprise a distal end portion (or section) 332, aproximal end portion (or section) 333, and an intermediate portion (orsection) 335, the intermediate portion 335 disposed between the distalend portion 332 and the proximal end portion 333.

In some embodiments, a distal end of the distal end portion 332 of theballoon 318 can be coupled to a distal end of the delivery apparatus300, such as to a nose cone 322 (as shown in FIGS. 9-11 ), or to analternate component at the distal end of the delivery apparatus 300(e.g., a distal shoulder). In some embodiments, the intermediate portion335 of the balloon 318 can overlay a valve mounting portion 324 of adistal end portion 309 of the delivery apparatus 300, the distal endportion 332 can overly a distal shoulder 326 of the delivery apparatus300, and the proximal end portion 333 can surround a portion of theinner shaft 308 (FIG. 10 ). The valve mounting portion 324 and theintermediate portion 335 of the balloon 318 can be configured to receivea prosthetic heart valve in a radially compressed state (e.g., as shownin FIGS. 41 and 42 , as described further below).

As described further below, rotation of the intermediate shaft 306results in rotation of the balloon 318 and the prosthetic valve mountedthereon for rotational positioning of the prosthetic valve relative tothe native anatomy at the target implantation site.

The balloon shoulder assembly is configured to maintain the prostheticheart valve or other medical device at a fixed position on the balloon318 during delivery through the patient's vasculature. The balloonshoulder assembly can include a distal shoulder 326 (FIGS. 9-11 )arranged within a distal end portion of the balloon 318 and coupled tothe distal end portion of the inner shaft 308. The distal shoulder 326can be configured to resist movement of the prosthetic valve or othermedical device mounted on the valve mounting portion 324 distally, in anaxial direction (e.g., along central longitudinal axis 320), relative tothe balloon 318.

For example, in some embodiments, the distal shoulder 326 can include aflared portion 331 arranged adjacent to the valve mounting portion 324(FIG. 10 ). In some embodiments, the flared portion 331 can include aplurality of wings 330 that flare radially outward from a base (e.g.,shaft) portion 325 of the distal shoulder 326 (FIG. 10 ), toward thevalve mounting portion 324 (as discussed in more detail below withreference to FIGS. 28, 32A-32B, and 40-42 ).

The outer shaft 304 can include a distal tip portion 328 mounted on itsdistal end (FIGS. 9 and 11 ). In some embodiments, the distal tipportion 328 can be configured as a flex adaptor including a plurality ofinner and outer helical grooves, as described further below withreference to FIGS. 38-41 . The outer shaft 304 and the intermediateshaft 306 can be translated axially relative to one another to positionthe distal tip portion 328 adjacent to a proximal end of the valvemounting portion 324, when a prosthetic valve is mounted in the radiallycompressed state on the valve mounting portion 324 and during deliveryof the prosthetic valve to the target implantation site (e.g., as shownin FIG. 41 ). As such, the distal tip portion 328 can be configured toresist movement of the prosthetic valve relative to the balloon 318proximally, in the axial direction, relative to the balloon 318, whenthe distal tip portion 328 is arranged adjacent to a proximal side ofthe valve mounting portion 324.

In some embodiments, the nose cone 322 can be disposed distal to and becoupled to the distal shoulder 326. In some embodiments, the nose cone322 can be coupled to the distal end portion of the inner shaft 308.

In some embodiments, the delivery apparatus 300 can comprise one or moremarkers or marker bands 353 that are configured to indicate to a user alocation of a specified component of the delivery apparatus. In someembodiments, the one or more marker bands 353 can radiopaque. In someembodiments, one or more marker bands 353 can be radially compressed(e.g., crimped) onto the inner shaft 308 (FIGS. 10 and 11 and also shownin FIGS. 32A and 40 ).

As shown in FIG. 10 , the distal end portion 332 of the balloon 318 caninclude a radial depression 334 that is depressed inward, toward thecentral longitudinal axis 320, relative to an outermost radial surfaceof the distal shoulder 326 and an outermost radial surface of the nosecone 322. The radial depression 334 is described in further detail belowwith reference to FIGS. 40 and 41 .

As shown in the detail, cross-sectional view of a selected portion 355(from FIG. 11 ) of the delivery apparatus 300 of FIG. 13 , an annularspace 336 can be defined between an outer surface of the inner shaft 308and an inner surface of the intermediate shaft 306. In some embodiments,the annular space 336 can be referred to as an inner lumen of theintermediate shaft 306. In some embodiments, the annular space 336 canbe configured to receive fluid from a fluid source via the second port340 of the adaptor 312 (e.g., the annular space 336 is in fluidcommunication with the second port 340 of the adaptor 312). The annularspace 336 can be fluidly coupled to a fluid passageway 342 formedbetween the outer surface of the distal end portion of the inner shaft308 and an inner surface of the balloon 318 (FIG. 10 ). As such, fluidfrom the fluid source can flow to the fluid passageway 342 from theannular space 336 to inflate the balloon 318 and radially expand anddeploy the prosthetic valve.

An inner lumen 344 of the inner shaft 308 (FIG. 13 ) can be configuredto receive a guidewire therethrough, for navigating the distal endportion 309 of the delivery apparatus 300 to the target implantationsite. As introduced above, the first port 338 of the adaptor 312 can becoupled to the inner lumen 344 and configured to receive the guidewire.For example, the distal end portion 309 of the delivery apparatus 300can be advanced over the guidewire, to the target implantation site.Exemplary guidewires are shown in FIGS. 29, 31A-31B, 34A-34B, and 59 ,as described further below.

As shown in the schematic of the intermediate shaft 306 in FIG. 12 andthe detail, cross-sectional view of the selected portion 355 (FIG. 11 )of the delivery apparatus 300 in FIG. 13 , in some embodiments, theintermediate (e.g., balloon) shaft 306 can include two layers of abraided (or coil) material that are configured to increase the torqueresistance of the intermediate shaft 306 so that it can withstandrotation at the target implantation site. The braided or coil materialcan comprise a more rigid braided or coiled material, such as metal orpolyethylene terephthalate (PET).

For example, the intermediate shaft 306 can be broken in a first portion346 that has a first length 356 and a second portion 354 that has asecond length 358, the first length 356 longer than the second length358 (FIG. 12 ). The first length 356 can be a majority of a total lengthof the intermediate shaft 306. In some embodiments, the second length358 can be in a range of 4 to 10 inches, 4 to 8 inches, or 5 to 7inches. In some embodiments, the second length 358 can be approximately6 inches. Thus, the first portion 346 can extend from the proximal endportion 310 of the intermediate shaft 306 to a distance (e.g., secondlength 358) away from the distal end 348 of the intermediate shaft 306.

The two layers of the braided material of the intermediate shaft 306 caninclude a first braided layer 350 that extends along an entire length ofthe intermediate shaft 306 (up until the distal end 348), along both thefirst portion 346 and the second portion 354 (FIG. 13 ). The two layersof the braided material of the intermediate shaft 306 can furtherinclude a second braided layer 352 that extends a majority of the entirelength of the intermediate shaft 306, along the first portion 346 (FIG.13 ). However, the second braided layer 352 stops before the secondportion 354 (FIGS. 12 and 13 ). This can allow the distal, secondportion 354 of the intermediate shaft 306 to have increased flexibilityat the distal end portion 316.

In alternate embodiments, the second braided layer 352 can extend theentire length of the intermediate shaft 306. In some alternateembodiments, the intermediate shaft 306 can include more than two layersof braided material, such as three.

As shown in FIGS. 9 and 14 , the handle 302 can include a steeringmechanism configured to adjust the curvature of the distal end portion309 of the delivery apparatus 300. In the illustrated embodiment, forexample, the handle 102 includes an adjustment member, such as theillustrated rotatable knob 360, which in turn is operatively coupled tothe proximal end portion of a pull wire. The pull wire can extenddistally from the handle 302 through the outer shaft 304 and has adistal end portion affixed to the outer shaft 304 at or near the distalend of the outer shaft 304. Rotating the knob 360 can increase ordecrease the tension in the pull wire, thereby adjusting the curvatureof the distal end portion 309 of the delivery apparatus 300. Furtherdetails on steering or flex mechanisms for the delivery apparatus can befound in U.S. Pat. No. 9,339,384, which is incorporated by referenceherein.

The handle 302 can further include an adjustment mechanism 361 includingan adjustment member, such as the illustrated rotatable knob 362, and ashaft 364 extending distally into a housing 366 of the handle 302. Theadjustment mechanism 361 is configured to adjust the axial position ofthe intermediate shaft 306 relative to the outer shaft 304 (FIGS. 9 and14 ). In some embodiments, as shown in FIG. 14 , an inner support 368 ismounted within the housing 366 on the intermediate shaft 306 and aninner shaft 370 (also referred to as a slider or sliding mechanism) ismounted on the inner support 368. The inner shaft 370 has a distal endportion 372 formed with external threads that mate with internal threadsthat extend along the inner surface of the shaft 364. The inner shaft370 further includes a proximal end portion 374 that mounts andinterfaces with a locking mechanism 376, which is configured to retain(e.g., lock) the position of the intermediate shaft 306 relative to thehandle 302. The inner shaft 370 can be coupled to the inner support 368such that rotation of shaft 364 causes the inner shaft 370 to moveaxially within the handle 302. The locking mechanism 376 can includeanother adjustment member, configured as a rotatable knob 378 housing aninner nut 380 with inner threads that engage the external threads of theproximal end portion 374 of the inner shaft 370.

To restrain movement of the intermediate shaft 306 for fine positioningof the prosthetic valve mounted on the distal end portion of thedelivery apparatus 300, the knob 378 is rotated, which in turn causesrotation of the inner nut 380. As a result, the inner nut 380 translatesin the distal direction along the external threads on the proximal endportion 374 of the inner shaft 370.

As the nut 380 is moved distally, additional components of the lockingmechanism 376 are configured to frictionally engage the intermediateshaft 306, thereby retaining the intermediate shaft 306 relative to theinner shaft 370. In the locked position, rotation of the knob 362 causesthe inner shaft 370 and the intermediate shaft 306 to move axiallyrelative to the outer shaft 304 (either in the proximal or distaldirection, depending on the direction the knob 362 is rotated).

Rotating the knob 378 in the opposite direction from the locked positionto the unlocked position allows axial and rotational movement of theintermediate shaft relative to the inner shaft 370 and the proximal endportion of the handle 302. Further details on the adjustment mechanism361 and locking mechanism 376 of the handle 302 can be found in U.S.Pat. No. 9,339,384, which is incorporated by reference herein.

As introduced above, the knob 314 of handle 302 can be configured torotate the intermediate (e.g., balloon) shaft 306, thereby rotating theballoon 318 mounted to the intermediate shaft 306 and a radiallycompressed prosthetic valve mounted on the balloon 318, around the valvemounting portion 324. Thus, rotating the knob 314 can rotate theprosthetic valve, around the central longitudinal axis 320, into adesired orientation relative to the native anatomy at the targetimplantation site.

FIGS. 15-22 show various views of an embodiment of the knob 314, whichis configured to rotate the intermediate shaft 306 upon rotation of theknob 314. In alternate embodiments, a differently configured rotatableknob or other adjustment mechanism can be used in place of knob 314, inorder to rotate the intermediate shaft 306 of the delivery apparatus300.

As shown in the perspective views of FIGS. 15 and 16 (and FIGS. 9 and 14, as described above), the knob 314 can be mounted on the proximal endportion 310 of the intermediate shaft 306, distal to the adaptor 312. Insome embodiments, the knob 314 can be directly coupled to and/orarranged around a portion or an entirety of the adaptor 312 (e.g., asshown in FIGS. 102-107 , described further below). In alternateembodiments, the knob 314 can be spaced axially away from the adaptor312.

The knob 314 can include an outer housing 382 arranged around (e.g.,housing) one or more internal components of the knob 314 (FIGS. 15-17and 20 ). In some embodiments, the outer housing 382 can include one ormore gripping elements 383 configured to increase traction or grip for auser rotating the knob 314. In some embodiments, the one or moregripping elements 383 can be raised elements or features that extendoutward from an outer surface of the outer housing 382 and are spacedapart from one another around a circumference of the outer housing 382.In alternate embodiments, the one or more gripping elements 383 can beraised ridges and/or depressed indentations in the outer housing 382.

In some embodiments, in order to increase an ease of assembly of theknob 314, the outer housing 382 can be split into two or more matingcomponents. For example, in some embodiments, as shown in FIGS. 15, 16,and 20 , the outer housing 382 can comprise a first housing portion 384and a second housing portion 385 that are configured to be removablycoupled to one another. For example, each of the first housing portion384 and the second housing portion 385 can include a correspondingmating interface configured to couple to the first housing portion 384and the second housing portion 385 to one another. In this way, thefirst housing portion 384 and the second housing portion 385 can becoupled to one another, around the intermediate shaft 306 and internalcomponents of the knob 314, thereby forming the knob (e.g., knobassembly) 314.

The knob 314 can further comprise an anchor 386 arranged within theouter housing 382 and configured to anchor (e.g., couple) the knob 314to the proximal end portion 310 of the intermediate shaft 306 (FIGS.17-19 ). FIG. 19 shows a cross-sectional view of the knob 314 with theanchor 386 coupled to the intermediate shaft 306 and the outer housing382 coupled around the anchor 386. FIGS. 18 and 19 show across-sectional view and perspective view, respectively, of the anchor386.

As shown in FIGS. 17-19 , the anchor 386 can comprise a shaft portion387 defining an inner lumen 388 configured to receive and couple aroundthe intermediate shaft 306. In some embodiments, the inner lumen 388 hasa relatively constant inner diameter.

In some embodiments, a distal end of the shaft portion 387 can includeone or more radial extensions 389 extending around at least a portion ofa circumference of the shaft portion 387 (FIGS. 17-19 ). In someembodiments, one or more or each of the radial extensions 389 can extendaround an entire circumference of the shaft portion 387. In someembodiments, the one or more radial extensions 389 can be configured asannular barbs that are axially spaced apart from one another.

The one or more radial extensions 389 can be configured to mate with aninterior of a sleeve element (which can also be referred to as a strainrelief element) 391 (FIG. 17 ). In some embodiments, the sleeve element391 can be arranged around a portion of the proximal end portion 310 ofthe intermediate shaft 306 and the outer housing 382 can include awider, first aperture 392 configured to receive therein and/or clamparound a proximal end of the sleeve element 391 (FIGS. 15-17 ). Thesleeve element 391 can be configured to relieve strain between the knoband the proximal end portion of the second shaft. In some embodiments,the sleeve element 391 can comprise a flexible and/or elastic materialsuch as an elastic polymeric material (e.g. rubber).

The outer housing 382 can further include a narrower, second aperture(e.g., channel) 393 configured to receive a distal portion of theadaptor 312 (FIGS. 17 and 20 ).

As shown in FIGS. 17-19 , the anchor 386 can comprise one or more or aplurality of extension portions (e.g., shafts or pins) 394 that areconfigured to mate with (e.g., extend into and/or couple with)corresponding channels or apertures 395 arranged in the outer housing382 (FIGS. 17 and 20 ). The extension portions 394 can be spaced apartfrom one another and extend radially outward from the shaft portion 387of the anchor 386.

In some embodiments, as shown in FIGS. 17-19 , the anchor 386 cancomprise two extension portions 394 extending from each of two oppositesides of the anchor 386. However, in alternate embodiments, the anchor386 can comprise more or less than four extension portions 394. A numberof the apertures 395 can be the same as the number of extension portions394.

In some embodiments, the apertures 395 and a mating portion of thecorresponding extension portions 394 can have a hexagonal shape.However, in alternate embodiments, other shapes are possible, such asrectangular, square, or the like.

In some embodiments, the anchor 386 can be configured for bonding (e.g.,UV bonding) to an outer surface of the intermediate shaft 306. Forexample, in some embodiments, the shaft portion 387 of the anchor 386can include one or more centering ribs 396 spaced apart around acircumference of the inner lumen 388 and extending along the inner lumen388 (FIGS. 18 and 19 ). In some embodiments, the shaft portion 387 caninclude a viewing aperture 397 (e.g., configured as a window) that canallow a user to view an alignment and/or bonding between the anchor 386and the intermediate shaft 306 (FIGS. 18 and 19 ). For example, as shownin FIG. 17 , the aperture 397 can extend between an outer surface and aninner surface of the shaft portion 387 and arranged in a central portionof the shaft portion 387. In some embodiments, a proximal end portion ofthe shaft portion 387 of the anchor 386 can include a counterbore 398(FIGS. 17 and 18 ). The counterbore 398 can enable enhanced UV bondingbetween the anchor 386 and the intermediate shaft 306.

The knob 314 can also include an aligning tab or extension 399 (FIGS.21-22 ) configured to align the adaptor 312 with a radiopaque markerarranged on the distal end portion 309 of the delivery apparatus 300(e.g., the marker 500 shown in FIG. 28 , the marker 600 shown in FIGS.32A-32B, or the marker 650 shown in FIG. 33 ). In some embodiments, asshown in FIGS. 21 and 22 , the aligning tab 399 can extend radiallyoutward from the anchor 386. In some embodiments, the aligning tab 399can extend radially outward from the shaft portion 387 of the anchor 386in a direction that is arranged perpendicular to a direction in whichthe extension portions 394 extend radially outward from the shaftportion 387 of the anchor 386. As described further below, duringassembly, the aligning tab 399 can be aligned with the second port 340of the adaptor 312, such that they extend outwardly relative to thecentral longitudinal axis 320 in a relatively same direction (e.g., bothpointing outward from a same side of the intermediate shaft 306, asshown in FIGS. 21 and 22 ).

In some embodiments, the knob 314 can be assembled to the proximal endportion 310 of the intermediate (e.g., balloon) shaft 306 in thefollowing manner. However, it should be noted that the below-describedmethod of assembly is exemplary and alternate assembly methods can bepossible.

In some embodiments, during assembly, the sleeve element 391 can bemounted on and/or around the proximal end portion 310 of theintermediate shaft 306. Then, the anchor 386 can be positioned on andaround the intermediate shaft 306, adjacent to the sleeve element 391.

In some embodiments, when the intermediate shat 306 is resting on arelatively planar surface (e.g., a table), the delivery apparatus 300can be positioned such that the radiopaque marker on the distal endportion 309 is pointing up (e.g., away from the table, which wouldappear in the plane of the page in FIG. 21 ) and the anchor 386 can bepositioned such that the aligning tab 399 is pointing away from the user(e.g., the person assembling the apparatus), as shown in FIG. 21 . Forexample, in FIG. 21 , the planar surface of table may be in the plane ofthe page. After this portion of the alignment is complete, the anchor386 can be bonded (e.g., via UV bonding) to the intermediate shaft 306and the sleeve element 391 can then be positioned over the radialextensions 389 of the anchor 386.

In some embodiments, the assembly method can further include bonding theadaptor 312 to the intermediate shaft 306 such that the second port 340is pointing in a same direction as the aligning tab 399 and/or thesecond port 340 and the aligning tab 399 are circumferentially aligned,relative to a circumference of the intermediate shaft 306 (FIGS. 21 and22 ). In this way, during an implantation procedure, a user may know aninitial (e.g., starting) position of the radiopaque marker on the distalend portion 309 of the delivery apparatus 300, within a patient. Thismay enable easier and faster rotational positioning of the radiopaquemarker, and thus the prosthetic valve, at the target implantation site,as described further below.

The outer housing 382 can then be positioned around the anchor 386 (FIG.22 ). In some embodiments, this can include positioning the firsthousing portion 384 and the second housing portion 385 around the anchor386 and coupling them to one another.

FIGS. 102-107 show various views of another embodiment of a knob (orhandle) 2500 which is configured to rotate the intermediate shaft 306 ofthe delivery apparatus 300 upon rotation of the knob 2500. The knob 2500(which can also be referred to as a handle or valve rotation control(VRC)) can be similar in function to the knob 314 (and include the sameor similar internal components, as described further below), except anouter housing 2502 of the knob 2500 is larger and configured to includeor enclose an adaptor (such as or similar to adaptor 312). Thus, in onespecific embodiment, the delivery apparatus 300 of FIG. 9 includes theknob 2500 instead of the knob 314.

As shown in the perspective and side views of FIGS. 102 and 103 ,respectively, the knob 2500 can be mounted on the proximal end portion310 of the intermediate shaft 306 and surround or include therein theadaptor 312 (or another, similar adaptor). For example, as shown inFIGS. 102-107 , the knob 2500 is arranged around and encloses thereinthe adaptor 312 such that a user cannot grab or rotate the adaptor 312independent of the knob 2500.

In some embodiments, the outer housing 2502 can include one or moregripping elements 2504 configured to increase traction or grip for auser rotating the knob 2500. In some embodiments, as shown in FIGS.102-107 , the one or more gripping elements 2504 can be raised elementsor features that extend radially outward from an outer surface of theouter housing 2502 and are spaced apart from one another around acircumference of the outer housing 2502. In alternate embodiments, theone or more gripping elements 2504 can be raised ridges and/or depressedindentations in the outer housing 2502.

In some embodiments, in order to increase an ease of assembly of theknob 2500, the outer housing 2502 can be split into two or more matingcomponents. For example, in some embodiments, as shown in FIG. 103 andthe exploded view of FIGS. 104 and 105 , the outer housing 2502 cancomprise a first housing portion 2506 and a second housing portion 2508that are configured to be removably coupled to one another. For example,each of the first housing portion 2506 and the second housing portion2508 can include a corresponding mating interface configured to couplethe first housing portion 2506 and the second housing portion 2508 toone another. In this way, the first housing portion 2506 and the secondhousing portion 2508 can be coupled to one another, around theintermediate shaft 306 and internal components of the knob 2500, therebyforming the knob (e.g., knob assembly) 2500.

Similar to the knob 314 of FIGS. 15-22 , the knob 2500 can comprise theanchor 386 arranged within the outer housing 2502 and configured toanchor (e.g., couple) the knob 2500 to the proximal end portion 310 ofthe intermediate shaft 306 (as shown in the cross-sectional side viewsof FIGS. 106 and 107 ). For example, the anchor 386 is configured tocouple around the intermediate shaft 306 and interface with the sleeveelement 391, as described above with reference to FIGS. 15-22 (and shownin FIGS. 106 and 107 ).

As described above with reference to FIGS. 15-22 , the outer housing1502 is configured to couple around and to the anchor 386 and receiveand/or clamp around a proximal end of the sleeve element 391. Forexample, similar to the outer housing 382 of knob 314, the outer housing2502 can comprise a first aperture 2510 (formed by the two halves of theouter housing 2502 when the two halves are coupled together) configuredto receive therein and/or clamp around the proximal end of the sleeveelement 391 (FIGS. 104-107 ).

The outer housing 2502 can further include an internal cavity 2512 (atits proximal end) configured to receive the adaptor 312 therein (FIGS.104-107 ). The outer housing 2502 can include a second aperture 2514(formed by the two halves of the outer housing 2502 when the two halvesare coupled together) that is configured to fit around the first port338 of the adaptor 312 (FIGS. 104-107 ). A proximal end of the firstport 338 can extend proximally out of and away from a proximal end 2516of the outer housing 2502 of the knob 2500. In some embodiments, theouter housing 2502 comprises a cap 2518 configured to couple around theproximal end 2516 when the first housing portion 2506 and the secondhousing portion 2508 are arranged together, thereby coupling the firsthousing portion 2506 and the second housing portion 2508 to one anotherand forming the closed outer housing 2502 (FIGS. 102, 103, 106 , and107).

The outer housing 2502 can further include an extension portion 2556that extends outward at an angle from a main body of the outer housing2502. A portion of the internal cavity 2512 can be formed within theextension portion 2556 and configured to receive the second port 340 ofthe adaptor 312. In some embodiments, the extension portion 2556 caninclude a third aperture 2558 (formed by the two halves of the outerhousing 2502 when the two halves are coupled together) that isconfigured to fit around the second portion 340 (FIGS. 104 and 107 ). Anopen end of the second port 340 can extend out of and away from thethird aperture 2558.

In alternate embodiments, instead of receiving the adaptor 312 withinthe internal cavity 2512, the adaptor and outer housing 2502 can beintegrated together (e.g., formed or molded as one piece).

Similar to the knob 314, as described above with reference to FIGS.15-22 , the outer housing 2502 of the knob 2500 can comprise one or moreapertures 395 that are arranged on an interior of the outer housing 2502and configured to receive and mate with the one or more extensionportions 394 of the anchor 386 (FIGS. 104-106 ). In some embodiments,each aperture 395 can be arranged in a radial extension member 2520extending from an inner surface of the outer housing 2502 (FIGS. 104-106).

In some embodiments, as described above with reference to FIGS. 21-22 ,the anchor 386 can include the aligning tab 399 which can extendradially outward from the anchor 386 (FIGS. 104 and 107 ). As describedabove and as shown in FIGS. 104 and 107 , during assembly, the aligningtab 399 can be aligned with the second port 340 of the adaptor 312, suchthat they extend outwardly relative to the central longitudinal axis 320in a relatively same direction (e.g., both pointing outward from a sameside of the intermediate shaft 306, as shown in FIGS. 104 and 107 ).

In some embodiments, the knob 2500 can be assembled to the proximal endportion 310 of the intermediate (e.g., balloon) shaft 306 in the same ora similar manner to the knob 314, as described above with reference toFIGS. 15-22 .

For example, in some embodiments, during assembly, the sleeve element391 can be mounted on and/or around the proximal end portion 310 of theintermediate shaft 306. Then, the anchor 386 can be positioned on andaround the intermediate shaft 306, adjacent to the sleeve element 391.In some embodiments, when the intermediate shat 306 is resting on arelatively planar surface (e.g., a table), the delivery apparatus 300can be positioned such that the radiopaque marker on the distal endportion 309 is pointing up (e.g., away from the table) and the anchor386 can be positioned such that the aligning tab 399 is pointing awayfrom the user. After this portion of the alignment is complete, theanchor 386 can be bonded (e.g., via UV bonding) to the intermediateshaft 306 and the sleeve element 391 can then be positioned over theradial extensions 389 of the anchor 386.

In some embodiments, the assembly method can further include bonding theadaptor 312 to the intermediate shaft 306 such that the second port 340is pointing in a same direction as the aligning tab 399 and/or thesecond port 340 and the aligning tab 399 are circumferentially aligned,relative to a circumference of the intermediate shaft 306. In this way,during an implantation procedure, a user may know an initial (e.g.,starting) position of the radiopaque marker on the distal end portion309 of the delivery apparatus 300, within a patient. This may enableeasier and faster rotational positioning of the radiopaque marker, andthus the prosthetic valve, at the target implantation site, as describedfurther below.

The outer housing 2502 can then be positioned around the anchor 386 andthe adaptor 312 (FIGS. 104-107 ). In some embodiments, this can includepositioning the first housing portion 2506 and the second housingportion 2508 around and coupling them to the anchor 386, therebycoupling distal ends of the first housing portion 2506 and the secondhousing portion 2508 to one another. The cap 2518 can then be coupled tothe proximal end 2516 of the knob 2500, thereby coupling proximal endsof the first housing portion 2506 and the second housing portion 2508 toone another. These connections may allow for the first housing portion2506 and the second housing portion 2508 to be held together withoutusing adhesive or additional fasteners.

In some embodiments, the outer housing 2502 can comprise one or moreindicators 2522 (e.g., markings) that indicate to a user which way theknob 2500 should be rotated in order to align the radiopaque marker onthe distal end portion of the delivery apparatus (e.g., marker 500 orany of the other markers described herein) with the guidewire runningthrough a center of the delivery apparatus (e.g., under fluoroscopyduring an implantation procedure, as described herein). For example, insome embodiments, each indicator 2522 can comprise a printed markingincluding a line representing the guidewire, a visual representation ofthe radiopaque marker on either side of the line (e.g., the “C” markersas shown), and an arrow on either side of the line indicating to theuser which way to rotate the knob 2500 if the radiopaque marker does notappear aligned with the guidewire in the selected imaging view duringthe implantation procedure, as described further herein (e.g., duringthe method at 1308, as described below with reference to FIG. 57 ).

For example, if the radiopaque marker on the distal end portion of thedelivery apparatus (e.g., marker 600 or another marker described herein)appears to be on a first side of the guidewire in the fluoroscopicimaging view, the user may rotate the knob 2500 in a first direction (asindicated by a first arrow of the indicator 2522) and if the radiopaquemarker appears to be on an opposite, second side of the guidewire in theimaging view, the user may rotate the knob 2500 in an opposite, seconddirection (as indicated by a second arrow of the indicator 2522) inorder to position the marker in alignment with the guidewire during theimplantation procedure. In some embodiments, as shown in FIGS. 102 and103 , each of the first housing portion 2506 and the second housingportion 2508 can include an indicator 2522 and the two indicators 2522(one on each housing portion) can be arranged 180 degrees apart from oneanother around the knob 2500.

In some embodiments, the presence of the knob 314 or the knob 2500 forrotating the intermediate shaft 306 to achieve a desired rotationalpositioning of the prosthetic valve at the target implantation site mayreduce a likelihood of the user holding onto and using the adaptor 312to rotate the intermediate shaft 306 and prosthetic valve. Such force ortorque applied to the adaptor 312 may result in damage to the adaptor312. Further, by fully encasing or enclosing the adaptor 312 within theknob 2500, as shown in FIGS. 102-107 , a user is prevented from holdingonto and applying torque to the adaptor 312.

In some embodiments, to further deter a user from holding and rotatingthe adaptor 312 for rotationally aligning the prosthetic valve, aportion of the adaptor 312 itself can be rotatable relative to theintermediate shaft 306 and a remainder of the adaptor 312.

For example, FIGS. 23-27 show an embodiment of a proximal end portion400 of a delivery apparatus, including an adaptor 402 comprising a firstport 404 and a second (e.g., inflation) port 406 that is configured torotate. In some embodiments, the proximal end portion 400 can be used asthe proximal end portion of the delivery apparatus 300 of FIGS. 9 and 14. Further, in some embodiments, the proximal end portion 400 can includesimilar components to those described above with reference to FIGS. 9and 14 , and thus, are labeled similarly in FIG. 23 .

As shown in FIG. 23 , the proximal end portion 400 can include a handle(e.g., handle portion), such as the handle 302 described above withreference to FIGS. 9 and 14 . However, in alternate embodiments, analternate handle configuration can be possible. A rotatable shaft, suchas the intermediate (e.g., balloon) shaft 306, can extend distally fromthe handle 302 (as shown in FIGS. 9 and 14 ) and have a proximal endportion 310 that extends proximally from the handle 302 to the adaptor402 (FIG. 23 ). Additionally, a rotatable knob 414 can be mounted on theproximal end portion 310 of the intermediate shaft 306, distal to theadaptor 402. The knob 414 can be configured to rotate the intermediateshaft 306. In some embodiments, the knob 414 can be knob 314, asdescribed above with reference to FIGS. 15-22 .

The adaptor 402 can further comprise an adaptor body (e.g., body) 408.The adaptor body 408 can be coupled (e.g., connected) to the proximalend portion 310 of the intermediate shaft 306 (FIGS. 23 and 26 ). Forexample, the adaptor body 408 can include a first inner channel 410(FIG. 25 ) configured to receive a proximal end of the intermediateshaft 306 therein (FIG. 26 ).

In some embodiments, an additional adaptor 442 can be arranged aroundthe intermediate shaft 306, between the knob 414 and the adaptor body408 (FIGS. 23 and 26 ).

The first port 404 can extend axially from the adaptor body 408 (FIGS.24-26 ). In some embodiments, the first port 404 can be directly and/orrigidly coupled to a proximal portion 412 of the adaptor body 408defining a second inner channel 416 of the adaptor body 408 (FIGS. 25-27). For example, in some embodiments, the first port 404 and the proximalportion 412 can be bonded together (e.g., via welding or an adhesive) atjoint 444 (FIG. 25 ).

In some embodiments, the first port 404 can be configured as a guidewireport that is adapted to receive a guidewire. For example, in someembodiments, a guidewire can be inserted into an opening 418 in thefirst port 404 and extend through the inner shaft 308, the inner shaft308 received within and extending through the second inner channel 416and the first inner channel 410. For example, as shown in FIGS. 26 and27 , a proximal end of the inner shaft 308 can be arranged and fitwithin a distal channel 420 of the first port 404 (FIGS. 25-27 ). Aguidewire can then be inserted into the opening 418 and extend throughan inner lumen defined by the inner shaft 308.

The second port 406 can extend radially outward from the adaptor body408, in a direction intersecting a central longitudinal axis 422 of theadaptor 402 and a central longitudinal axis (e.g., central longitudinalaxis 320) of the delivery apparatus (FIG. 25 ). In some embodiments, thesecond port 406 can extend radially outward from the adaptor body 408 atan angle that is between 10 and 90 degrees from the central longitudinalaxis 422. In some embodiments, the second port 406 can extend radiallyoutward from the adaptor body 408 in a direction that is perpendicularto the central longitudinal axis 422.

The second port 406 is rotatably coupled to the adaptor body 408. Forexample, as shown in FIGS. 25-27 , the second port 406 can be rotatablycoupled to the proximal portion 412 of the adaptor body 408. In someembodiments, the second port 406 can include a base portion 424 arrangedaround the proximal portion 412 of the adaptor body 408.

A seal 426 can be arranged between the base portion 424 and the proximalportion 412 of the adaptor body 408 (FIGS. 25-27 ). In some embodiments,the seal 426 can be a circumferential or ring-like seal that extendsaround an outer surface of the proximal portion 412 of the adaptor body408 (e.g., around the circumference). In some embodiments, the seal 426can comprise one or more O-ring seals or a quad ring seal.

The second port 406 can further include an inner channel (forming aninner lumen) 432 extending from an opening 428 in the second port 406,through a shaft portion 430 of the second port 406, and through aportion of the base portion 424 connected with the shaft portion 430.The shaft portion 430 can extend radially outward from one side of thebase portion 424.

The proximal portion 412 of the adaptor body 408 can include an annulargroove 434 defining an annular channel 436 extending around at least aportion of a circumference of the proximal portion 412 of the adaptorbody 408 (as best seen in FIGS. 25 and 27 ). In some embodiments, theannular channel 436 can fluidly couple the inner channel 432 to anannular space 438 defined between the outer surface of the inner shaft308 and inner surface of the proximal portion 412 of the adaptor body408 (FIGS. 26 and 27 ).

In some embodiments, one or more apertures 440 extending radially inwardfrom the annular groove 434 can fluidly connect the annular space 438with the inner channel 432 (FIGS. 25 and 27 ). The annular space 438 canbe fluidly coupled to the annular space 336 defined between the outersurface of the inner shaft 308 and the inner surface of the intermediateshaft 306 (FIG. 26 ). In alternate embodiments, the annular groove 434can extend through a thickness of the proximal portion 412 of theadaptor body 408 in order to fluidly couple the inner channel 432 withthe annular space 438.

In this way, fluid (e.g., inflation fluid) can flow from the innerchannel 432, to the annular space 438, to the annular space 336, andinto the inflatable balloon (e.g., balloon 318 described above withreference to FIGS. 9-14 ), while allowing the second port 406 to rotatearound the adaptor body 408 (e.g., around the central longitudinal axis422). As a result, a user may be deterred from attempting to rotate theintermediate shaft 306 via rotating the adaptor 402 (e.g., since doingso may result in the second port 406 rotating around the adaptor body408). Further, rotating the second port 406 can avoid torque from beingapplied to the adaptor body 408 and the first port 404, therebyincreasing a durability and longevity of the adaptor 402 and preventinga bond between the adaptor 402 and the intermediate shaft 306 from beingcompromised. As a result, a likelihood of more effective and consistentdeployment of the balloon (e.g., balloon 318) via injection of aninflation fluid via the second port 406 can be increased. Further still,having a rotatable second port 406 can allow a user to position thesecond port 406 in a variety of positions (for injecting the inflationfluid) without causing unwanted movement of the delivery apparatus.

As described above with reference to FIGS. 9-27 , the delivery apparatus300 and/or similarly configured delivery apparatuses can include one ormore features that facilitate the rotational alignment of a radiallycompressed prosthetic valve, arranged on a distal end portion of thedelivery apparatus, at the target implantation site.

As introduced above, it may be desirable to implant a prosthetic heartvalve in a native valve with a delivery apparatus (such as deliveryapparatus 300 of FIGS. 9-14 ) such that commissures of the prostheticheart valve are aligned with commissures of the native valve. In someembodiments, in order to facilitate the desired rotational positioningof the prosthetic heart valve relative to the native valve, a radiopaquemarker that is visible under medical imaging can be arranged on orembedded in a portion of the distal end portion (such as a polymericbody mounted on a distal end portion of a shaft) of the deliveryapparatus which is disposed proximate to the valve mounting portion(e.g., valve mounting portion 324) of the delivery apparatus, and thusthe radially compressed prosthetic valve. As described further below, insome embodiments, the radiopaque marker can be configured to indicate alocation of a selected commissure of the prosthetic valve after radiallyexpanding the prosthetic valve via inflating a balloon of the deliveryapparatus (e.g., balloon 318 of FIGS. 9-11 ).

FIGS. 28-34B show embodiments of a radiopaque marker arranged on orembedded in a portion of a delivery apparatus, such as deliveryapparatus 300 shown in FIGS. 9-14 . Though delivery apparatus 300 isshown by way of example in FIGS. 28, 29, and 32A-32B, in alternateembodiments, the radiopaque marker can be arranged on or embedded withina portion of an alternate delivery apparatus configured to deliver aradially compressed prosthetic valve to a target implantation site. Insome embodiments, the portion of the delivery apparatus that theradiopaque marker is arranged on or embedded within can be a polymericbody mounted on a shaft at the distal end portion of the deliveryapparatus. For example, the polymeric body can be one or more of aproximal shoulder, a distal shoulder (e.g., distal shoulder 326 in FIGS.9-11 ), or a nose cone (e.g., nose cone 322 in FIGS. 9-11 ) mounted toan inner shaft of the delivery apparatus and/or to another polymericbody mounted to the inner shaft.

FIG. 28 shows a radiopaque marker 500 positioned on and/or embeddedwithin a polymeric body of distal end portion of a delivery apparatus(e.g., delivery apparatus 300 shown as an example in FIGS. 28 and 29 ).In some embodiments, as shown in FIG. 28 , the distal shoulder 326 ofthe distal end portion 309 of the delivery apparatus 300 can include themarker 500 arranged on and/or embedded therein.

As shown in FIG. 28 and explained above with reference to FIGS. 9-11 ,the inflatable balloon 318 is arranged over (e.g., overlays) the distalshoulder 326 and the valve mounting portion 324. The nose cone 322 isarranged at a distal end of the delivery apparatus 300 and is arrangedadjacent (and distal to) to the distal shoulder 326. As explained above,the valve mounting portion 324 is configured to receive a radiallycompressed prosthetic valve thereon, around the balloon 318. The distalshoulder 326 can be configured such that when a prosthetic valve ismounted on the balloon 318 in a radially compressed state, at the valvemounting portion 324, the distal shoulder 326 resists movement of theprosthetic valve relative to the balloon 318 in an axial direction(which is arranged along and relative to the central longitudinal axis320 of the delivery apparatus 300).

The nose cone 322 and/or the distal shoulder 326 may comprise one ormore polymeric materials, and thus, may be referred to herein aspolymeric bodies. In some embodiments, the distal end portion 309 of thedelivery apparatus 300 can have additional polymeric bodies orcomponents, such as a proximal shoulder arranged on an opposite side ofthe valve mounting portion 324 from the distal shoulder 326.

The marker 500 can be configured to be visible under medical imaging.For example, the marker 500 can comprise a radiopaque material that isconfigured to be visible under medical imaging, such as fluoroscopyand/or other types of X-ray imaging. In some embodiments, the marker 500can comprise a radiopaque or other material that is configured to bevisible under MRI, ultrasound, and/or echocardiogram. The polymericbody, such as the distal shoulder 326, that the marker 500 is arrangedon and/or embedded within can be configured such that it is notradiopaque. As a result, the marker 500 can be more easily visible underimaging, as described further below with reference to FIG. 29 .

Though the marker 500 is shown positioned on and/or embedded within thedistal shoulder 326 in FIG. 28 , in alternate embodiments, the marker500 can be arranged on and/or embedded within another polymeric body orcomponent of the distal end portion 309 of the delivery apparatus. Forexample, in some embodiments, the marker 500 can be positioned on and/orembedded within the nose cone 322 or a proximal shoulder of a deliveryapparatus (e.g., proximal shoulder 120 shown in FIG. 3 ).

The marker 500 can have various shapes or patterns. For example, thoughthe marker 500 is shown in FIGS. 28 and 29 as a dot, in alternateembodiments, the marker 500 can be configured as a different shape orsymbol, such as a circle, rectangle, star, square, triangle, “X”, or thelike. Additional embodiments of the shape of the marker are describedbelow with reference to FIGS. 30-34B.

As shown in FIG. 28 , the marker 500 is arranged on and/or embeddedwithin a portion of the distal shoulder 326. In some embodiments, theportion of the distal shoulder 326 in which the marker 500 is arrangedon and/or embedded within may be a portion of the distal shoulder 326that is disposed closer to (e.g., adjacent to) the valve mountingportion 324 than a remaining portion of the distal shoulder 326. Thus,when the radially compressed prosthetic valve is arranged on the valvemounting portion 324, the marker 500 may be arranged proximate andadjacent to the prosthetic valve.

In some embodiments, as shown in FIG. 28 , the distal shoulder 326 cancomprise the base portion 325 and the flared portion 331. The flaredportion 331 can extend radially outward from the base portion 325,toward the valve mounting portion 324. The marker 500 can be arranged onand/or be embedded within the flared portion 331, thereby orienting themarker 500 radially outward from an outer surface of the inner shaft308. In alternate embodiments, the marker 500 can be arranged on and/orembedded within the base portion 325.

In some embodiments, as shown in FIG. 28 , the flared portion 331 cancomprise the plurality of wings 330 (which can also be referred to asextension portions) that extend radially outward from the base portion325, at an angle relative to the central longitudinal axis 320. Thewings 330 can be spaced apart from one another around a circumference ofthe flared portion 331. As shown in FIG. 28 , in some embodiments, themarker 500 can be positioned on or embedded in one of the wings 330. Insome embodiments, the marker 500 can be centered on one of the wings330, such that it is centered along the central longitudinal axis 320.

In some embodiments, the marker 500 can be a single (e.g., the only)radiopaque marker arranged on the distal shoulder 326. In someembodiments, the marker 500 can be the only (or single) radiopaquemarker arranged on the distal end portion 309 of the delivery apparatus300.

In some embodiments, the distal end portion 309 of the deliveryapparatus 300 can include additional radiopaque markers (in addition tomarker 500).

Arranging the marker 500 on or in the distal shoulder 326, or anotherpolymeric body of the distal end portion of the delivery apparatus, canallow the marker 500 to be more visible under imaging, such asfluoroscopy, since a remainder of the distal shoulder 326 can be less ornon-radiopaque, and thus, can be less, or not, visible in thefluoroscopic image. For example, as shown in the exemplary fluoroscopicimage 550 of FIG. 29 , the marker 500 is visible under fluoroscopy andstands out since the distal shoulder is not radiopaque (other than themarker 500). In contrast, the prosthetic valve frame 552 is radiopaqueand visible under imaging. Thus, a radiopaque marker positioned onand/or in the prosthetic valve itself may be more difficult to see underimaging since the valve frame appears relatively dark in the image 550.

As also shown in FIG. 29 , a guidewire 554 extending through a center ofthe distal end portion 309 of the delivery apparatus (e.g., through theinner lumen of the inner shaft 308) is visible under fluoroscopy and themarker 500 is positioned radially outward of the guidewire 554 (e.g.,due to the marker 500 being positioned on the flared portion 331 of thedistal shoulder 326). This further increases the visibility of themarker 500 under imaging, during an implantation procedure.Additionally, as described further below, when the marker 500 isarranged in a direct back or direct front of the imaging view, themarker 500 can appear to overlap the guidewire.

Additionally, arranging the marker 500 on or in the distal shoulder 326(or another polymeric body of the distal end portion of the deliveryapparatus) can allow for more accurate alignment with the commissures ofthe native valve. For example, as described further below, it may bedesirable to rotationally align the marker 500 with a target commissureof the native valve, prior to crossing the leaflets of the native valve.Thus, when rotating the distal end portion 309 of the deliveryapparatus, including the distal shoulder 326 and the prosthetic valve,to align the marker 500 with the target commissure of the native valve,it may be advantageous for the marker 500 to be arranged as far distalon the delivery apparatus as possible so that it is positioned as closeas possible to the target commissure of the native valve. As shown inFIG. 28 , the distal shoulder 326 (and the nose cone 322) is one of themost distal components of the delivery apparatus 300 and is arrangedfurther distal than the radially compressed prosthetic valve (e.g.,further distal than the valve mounting portion 324, as seen in FIG. 28).

Arranging the marker 500 on or in the distal shoulder 326 (or anotherpolymeric body of the delivery apparatus that is positioned offset fromthe prosthetic valve, in the axial direction) also allows the marker 500to be offset, in a circumferential direction, from a selected commissureof the prosthetic valve. For example, as described further below, sincethe prosthetic valve rotates upon inflation of the inflatable balloon318, the marker 500 can be offset in the circumferential direction fromthe selected commissure of the prosthetic valve to compensate for thisrotation. As a result, after deployment of the prosthetic valve, theselected commissure of the prosthetic valve may be aligned with thetarget commissure of the native valve. If the prosthetic valve itselfhad an offset marker, this may be confusing after valve deployment sincethe maker would be visible but not actually mark the selected commissureof the prosthetic valve.

Further still, providing the marker 500 on or in the distal shoulder 326(or another portion of the delivery apparatus, proximate to the valvemounting portion 324) may avoid having to add an additional component tothe relatively permanent implant (e.g., prosthetic valve).

Additionally, changes to the marker 500 (e.g., design changes) on thedelivery apparatus may be more easily implemented on the deliveryapparatus than if the marker 500 were on the valve (e.g., due to valvetesting as a result of any design modifications to the prostheticvalve).

During an implantation procedure, a selected imaging view (e.g.,fluoroscopic imaging view) can be used to visualize the distal endportion of the delivery apparatus, including the marker 500 and theradially compressed prosthetic valve (e.g., frame 552) relative to thesurrounding native anatomy. Based on an existing knowledge of a locationof a selected commissure of the native valve (in which the prostheticvalve is to be implanted) within the selected imaging view, a user canrotationally align the distal end portion of the delivery apparatus atthe target implantation site, such that the marker 500 is aligned withthe known location of the selected commissure, in the selected imagingview, or such that the marker 500 is arranged in a certain positionwithin the selected imaging view (e.g., direct back) and deploying theprosthetic valve in such an orientation will result in commissurealignment between the prosthetic valve and the native valve.

For example, in some imaging views, the selected commissure of thenative valve can be arranged in a direct back of the imaging view. Thus,by aligning the marker 500 on the delivery apparatus with the directback of the imaging view, the prosthetic valve can be implanted withinthe native valve with commissure alignment between the native valve andprosthetic valve.

Exemplary fluoroscopic imaging views obtained during a prosthetic valveimplantation procedure and used to guide the delivery apparatusproximate to the native valve are shown in FIGS. 58, 61, and 63 , asdescribed further below.

To enable the desired positioning of the marker within the selectedimaging view, in some embodiments, the marker can be configured as anasymmetric marker which is then aligned with a guidewire extendingthrough the delivery apparatus, along a central longitudinal axis of thedelivery apparatus. For example, the asymmetric marker can be reflectionasymmetric along an axis that is parallel to the central longitudinalaxis of the delivery apparatus. In this way, under medical imaging, suchas fluoroscopy, a position of the marker within the imaging view,relative to the guidewire (e.g., a front vs. a back of the imagingview), can be more easily discerned.

FIGS. 30-34B show example embodiments of such an asymmetric marker thatallows a user to differentiate between two different positions of themarker within the imaging view. For example, in some embodiments, theasymmetric marker is configured such that a user viewing the imagingview can differentiate between the marker being positioned in a front ora back of the fluoroscopic imaging view. The markers shown in FIGS.30-34B can be positioned on the delivery apparatus, as described abovewith reference to FIGS. 28 and 29 . For example, in some embodiments,the markers shown in FIGS. 30-34B can replace marker 500 (FIGS. 28 and29 ) on the distal shoulder 326 or an alternate polymeric body of thedistal end portion 309 of the delivery apparatus.

In some embodiments, the asymmetric marker can be a letter of thealphabet (e.g., as shown in FIGS. 30-34B), a number, a symbol, a shape,or the like, that is reflection asymmetric along an axis that isparallel to the central longitudinal axis of the delivery apparatus. Forexample, the asymmetric marker can have a first orientation where it canbe read “correctly” or forward (e.g., not backward) and a secondorientation that is approximately 180 degrees rotated around the axisfrom the first orientation, which results in the marker appearingbackward to a reader (e.g., user).

FIG. 30 shows a first exemplary embodiment of an asymmetric marker 600that is shaped as a letter “C” and can be configured similarly to marker500 of FIG. 28 (e.g., radiopaque). The C-shaped asymmetric marker 600 isreflection asymmetric across a longitudinal axis 602 which, whenpositioned on a delivery apparatus (e.g., delivery apparatus 300), asdescribed above with reference to FIG. 28 , is parallel to the centrallongitudinal axis of the delivery apparatus. For example, in FIG. 30 ,the C-shaped asymmetric marker 600 is in a first orientation which isits forward-readable orientation (e.g., appears in its correct, notbackward, orientation to a reader). If the C-shaped asymmetric marker600 were rotated by approximately 180 degrees around its longitudinalaxis 602, the C-shaped asymmetric marker 600 would be in a secondorientation and the “C” would appear backward (e.g., flipped). These twoorientations of the C-shaped asymmetric marker 600 can be seen in amedical imaging view (e.g., using fluoroscopy), as explained furtherherein. The two orientations of the C-shaped asymmetric marker (andother asymmetric markers described herein) can be mirror images of oneanother.

FIGS. 31A and 31B show exemplary fluoroscopic images 610 and 612,respectively, of a guidewire 606 extending through a distal end portionof a delivery apparatus (e.g., distal end portion 309 of deliveryapparatus 300) and the C-shaped asymmetric marker 600 arranged on orembedded within a portion of the distal end portion of the deliveryapparatus (e.g., the distal shoulder 326, as shown in FIG. 28 ). Asshown in the first fluoroscopic image 610 of FIG. 31A, the C-shapedasymmetric marker 600 is aligned with (e.g., overlapping) the guidewire606 and the “C” is readable, in its first (forward) orientation. In someembodiments, this position of the marker 600 shown in FIG. 31A mayindicate the marker 600 is arranged behind the guidewire 606 within thefirst fluoroscopic imaging view 610, and thus, in the direct back of theimaging view. In alternate embodiments, the position of the marker shownin FIG. 31A may indicate the marker is arranged in front of theguidewire 606, and thus, in the direct front of the imaging view.

In contrast, when the delivery apparatus is rotated by approximately 180degrees from its orientation shown in FIG. 31A, the C-shaped asymmetricmarker 600 is correspondingly rotated and appears in its second(backward) orientation wherein the “C” is backward, as shown in FIG.31B. In some embodiments, the position of the marker 600 shown in FIG.31B may indicate the marker 600 is arranged in front of the guidewire606 within the imaging view, and thus, in the direct front of theimaging view. In alternate embodiments, the position of the marker 600shown in FIG. 31B may indicate the marker is arranged behind theguidewire 606, and thus, in the direct back of the imaging view.

In this way, by viewing an orientation of a reflection asymmetricmarker, such as marker 600, relative to the guidewire 606, within aselected imaging view, the position of the marker 600 at an implantationsite (e.g., proximate to the target native valve) can be more easily andquickly determined. Further details on rotationally aligning the markerrelative to a guidewire such that the prosthetic valve is implanted withcommissures in aligned with commissures of the native valve is explainedbelow with reference to FIGS. 57-60 .

FIGS. 32A and 32B show a side view and perspective view, respectively,of an exemplary positioning of the asymmetric marker 600 (shaped as theletter “C”) on and/or embedded within the distal shoulder 326 of thedistal end portion 309 of the delivery apparatus 300. As shown in FIGS.32A and 32B, the marker 600 can be positioned on the distal shoulder 326(e.g., on a wing 330, in some embodiments) such that when the deliveryapparatus is arranged within a patient's vasculature, and a longitudinalimaging view similar to the view of image 550 in FIG. 29 is used tovisualize the delivery apparatus, the C-shape of the marker 600 will beread in the backward orientation when the marker 600 is in the directfront of the imaging view and the marker 600 will be read in the forwardorientation when the marker 600 is positioned in the direct back of theimaging view.

In alternate embodiments, the marker 600 can be oriented differently onthe distal shoulder that what is shown in FIGS. 32A and 32B, such thatthe marker 600 is rotated by 180 degrees and is instead read in theforward orientation when the marker 600 is in the direct front of theimaging view.

FIGS. 33-34B show a second exemplary embodiment of an asymmetric marker650 that is shaped as a letter “E” and can be configured similarly tomarker 500 of FIG. 28 (e.g., radiopaque). FIG. 33 shows the E-shapedasymmetric marker 650 alone while FIGS. 34A and 34B show fluoroscopicimages of the E-shaped asymmetric marker 650, on a delivery apparatus,in two different orientations relative to the guidewire 606.

The E-shaped asymmetric marker 650 may be configured and functionsimilarly to the marker 600, as described above with reference to FIGS.30-32B, other than its overall shape (e.g., E instead of C shape). Forexample, the E-shaped asymmetric marker 650 can be reflection asymmetricacross a longitudinal axis 652 which, when positioned on a deliveryapparatus, is parallel to the central longitudinal axis of the deliveryapparatus.

Similarly to marker 600, the E-shaped asymmetric marker 650 has a firstorientation which is its forward (or “correct”) readable orientation (asshown in FIG. 33 and the first image 654 of FIG. 34A). The E-shapedasymmetric marker 650 also has a second orientation, which is rotated byapproximately 180 degrees around its longitudinal axis 652 from thefirst orientation. In the second orientation, the “E” appears backward(as shown in the second image 656 of FIG. 34B). These two orientationsof the E-shaped asymmetric marker 650 can be seen with medical imaging(e.g., fluoroscopy), as shown in FIGS. 34A and 34B and explained furtherherein.

In some embodiments, the E-shaped asymmetric marker 650 can replace themarker 600 on the delivery apparatus shown in FIGS. 32A and 32B.

In yet other embodiments, an asymmetric marker can be shaped as anotherletter (other than “C” or “E”, such as “P” or “F”), a number, a symbol,a shape, or the like, which is reflection asymmetric, as describedabove, and has two differentiable orientations when rotatedapproximately 180 degrees around its reflection asymmetric axis.

In some embodiments, the asymmetric marker (e.g., marker 600 or marker650) arranged on or embedded within the distal end portion of thedelivery apparatus (such as the distal shoulder 326) can comprise aradiopaque material. In some embodiments, the radiopaque materialcomprises metal.

In some embodiments, the asymmetric markers described herein cancomprise tantalum.

In some embodiments, the asymmetric markers described herein cancomprise another type of radiopaque material or combination ofmaterials, such as one or more of iodine, barium, barium sulfate,tantalum, bismuth, or gold.

In some embodiments, the asymmetric markers described herein cancomprise a platinum-iridium alloy. In some embodiments, an alloyproportion of the platinum-iridium alloy is 90:10. In some embodiments,the alloy proportion of the platinum-iridium alloy is in a range of75:25 to 95:5. In some embodiments, the alloy proportion of theplatinum-iridium alloy is in a range of 85:15 to 95:5.

In some embodiments, instead of or in addition to being positioned onthe distal end portion of the delivery apparatus, a radiopaque markercan be positioned on a prosthetic valve, such as on or near a commissureof the prosthetic valve, as shown in FIGS. 35A-35P and 97-101E. As aresult, a location of a selected commissure of the radially compressedprosthetic valve can be identified by medical imaging during a valveimplantation procedure and rotationally aligned with the native anatomyat the target implantation site.

In embodiments where radiopaque markers are disposed both on the distalend portion of the delivery apparatus (as described above) and on theprosthetic valve (at or near the commissure, as described below), afirst radiopaque marker on the delivery apparatus can be visualizedduring the valve implantation procedure to rotationally align the firstmarker with the native anatomy and deploy the prosthetic valve such thatits commissure are aligned with commissures of the native valve. Then asecond radiopaque marker on the prosthetic valve can be visualized afterimplantation (e.g., during future interventions to locate the prostheticvalve commissures and/or to confirm the location of the prosthetic valvecommissures relative to the native valve commissures). In someembodiments, the second radiopaque marker at the commissure of theprosthetic valve can be more easily visualized after radial expansion ofthe prosthetic valve (after implantation).

An exemplary embodiment of a radiopaque marker 700 attached to acommissure 702 of a prosthetic valve 704 (which may be similar to any ofthe prosthetic valves described herein, such as prosthetic valve 10 ofFIG. 1 or prosthetic valve 50 of FIGS. 2A and 2B), is shown in FIGS. 35Aand 35B. FIG. 35A shows the prosthetic valve 704 in a radiallycompressed configuration (e.g., state), such as when it is arrangedaround and crimped onto a delivery apparatus, and FIG. 35B shows theprosthetic valve 704 in a radially expanded configuration (e.g., state).

As introduced above with reference to FIGS. 2A and 2B and as shown inFIGS. 35A and 35B, in some embodiments, commissures 702 of theprosthetic valve 704 can comprise an attachment member 706 arrangedacross a cell (e.g., commissure cell) 708 of the frame 710 of theprosthetic valve 704. In some embodiments, the attachment member cancomprise a fabric, flexible polymer, or the like arranged across thecell 708. As explained herein, the cell 708 can be formed by struts 712of the frame 710. The attachment member 706 can be arranged across thecell 708 and secured to the struts 712 of the frame 710 forming the cell708 via fasteners 714 (e.g., sutures). Additionally, adjacent portionsof two leaflets 716 of the prosthetic valve 704 can be connected to theattachment member 706 to form the commissure 702.

In some embodiments, the commissure tabs of two adjacent leaflets 716are coupled to the attachment member 706, on an inner surface (shown inFIG. 35E, as described below) of the attachment member 706, and themarker 700 is disposed on an outer surface 724 of the attachment member706. The inner surface can be arranged opposite the outer surface 724,facing an interior of the prosthetic valve 704.

In some embodiments, as shown in FIGS. 35A and 35B, the marker 700 canbe arranged on a central region of the commissure cell 708. For example,in some embodiments, the marker 700 can be sewn to a central region ofthe attachment member 706 via one or more fasteners (e.g., sutures) 722.

In some embodiments, the marker 700 can be shaped and positioned suchthat it fits within the cell 708 when the frame 710 is in the radiallycompressed configuration, as shown in FIG. 35A.

In some embodiments, the commissure cell 708 can be arranged at anoutflow end 718 of the prosthetic valve 704.

In some embodiments, the marker 700 comprises tantalum, or anotherradiopaque material described herein or known in the art, which isformed or laser cut into a shape that is reflection asymmetric acrossthe axis, similar to as described above with reference to FIGS. 28-34B.

In some embodiments, the prosthetic valve 704 includes a skirt 720 (FIG.35B) arranged around the frame 710 of the prosthetic valve 704, at aninflow end of the prosthetic valve 704 (e.g., an end arranged oppositethe outflow end 718). As shown in FIGS. 35A and 35B, when the commissurecell 708 is arranged at the outflow end 718 of the prosthetic valve 704,the commissure cell 708 including the marker 700 can be spaced away, inan axial direction, from the skirt 720.

FIGS. 35C-35H show another exemplary embodiment of attachment of aradiopaque marker 750 to a commissure within a cell 708 of a prostheticvalve. The prosthetic valve shown in FIGS. 35C-35H can be the sameprosthetic valve 704 as shown in FIGS. 35A and 35B, and thus FIGS.35C-35H are labeled accordingly. However, in FIGS. 35C-35H, there aretwo attachment members arranged across the cell 708 and attached to thestruts 712 forming the cell 708. The commissure tabs 754 of the leaflets716 and the marker 750 can be sutured to different attachment members ofthe two attachment members.

For example, the attachment member 706 to which the commissure tabs 754of the leaflets 716 are attached can be a first attachment member 706(FIGS. 35C, 35D, and 35H) and the marker 750 can be attached to a secondattachment member 752 (FIGS. 35C-35G).

The marker 750 can be similar to the marker 700 and the other radiopaquemarkers described herein. For example, the marker 750 can be configured(e.g., shaped and sized) such that it fits within the cell 708 when theframe 710 is in the radially compressed configuration (e.g., as shown inFIG. 35A).

An exemplary embodiment of the marker 750 is shown in FIG. 35I. Themarker 750 can be oval-shaped with a first (upper) aperture 726 and asecond (lower) aperture 728 configured to receive fasteners (e.g.,sutures) for securing the marker 750 to an attachment member, asdescribed further below. In some embodiments, the marker can includemore or less than two apertures (e.g., one, three, four, or the like)for receiving fasteners. In some embodiments, the marker 750 can have adifferent shape configured to fit within the cell 708 when the frame 710is radially compressed, such as one of the other marker shapes andembodiments described herein (e.g., with reference to FIGS. 35A, 35B,and 35J-35P).

In some embodiments, the marker 750 can be shaped as a letter of thealphabet (e.g., as shown in FIGS. 35A and 35B).

In some embodiments, the marker 750 can be reflection asymmetric acrossan axis that is parallel to a central longitudinal axis 760 of the frame710 (e.g., as shown in FIGS. 35A and 35B).

As shown in FIG. 35C, the first attachment member 706 can be secured tothe struts 712 forming the cell 708 via fasteners (e.g., sutures) 714.Commissure tabs 754 of two adjacent leaflets 716 can be coupled to thefirst attachment member 706, at an inner surface 756 of the firstattachment member 706, as shown in FIG. 35H (commissure tabs 754 areidentified by region 755 in FIG. 35C). For example, commissure tabs 754can be sutured directly to the inner surface 756 of the first attachmentmember 706 or via one or more intervening layers of fabric betweencommissure tabs 754 and the first attachment member 706.

As also shown in FIG. 35C, the marker 750 is secured to the secondattachment member 752 via one or more fasteners 758 (e.g., sutures) thatcan extend through the first aperture 726 and second aperture 728 in themarker 750 (FIG. 35I). In some embodiments, the marker 750 can be sewn,with the fasteners 758, to a central region of the second attachmentmember 752.

In other embodiments, the marker 750 can have another number ofapertures or a different shape configured to receive the fasteners 758for securing the marker 750 to the second attachment member 752. Forexample, in some embodiments, the marker 750 can be ring-shaped (e.g.,shaped as the letter, “O”).

FIG. 35C shows the marker 750 attached to the second attachment member752, but before the second attachment member 752 is assembled to theframe 710. FIG. 35G shows the marker 750 and the second attachmentmember 752 after the second attachment member 752 is positioned at thecommissure cell 708, such that the marker is disposed between the firstattachment member 706 and the second attachment member 752, and suturedto the struts of the frame with one or more sutures 762. In this way,opposite sides of the second attachment member 752 are shown in FIGS.35C and 35G.

In some embodiments, as shown in FIG. 35G, the second attachment member752 can be arranged, relative to the frame 710, such that an exposedmetal material of the marker 750 faces the frame 710 and the outersurface 724 of the first attachment member 706.

Thus, when the second attachment member 752 is arranged across the cell708 and attached to the struts 712 forming the cell 708, as shown inFIG. 35G, the marker 750 can be sandwiched (e.g., disposed) between thesecond attachment member 752 and the first attachment member 706.

In some embodiments, the second attachment member 752 can comprise afabric material, similar to or the same as the first attachment member706.

In some embodiments, the second attachment member 752 can be secured tothe struts 712 via additional fasteners (e.g., sutures).

In other embodiments, as shown in FIGS. 35D-35F, the second attachmentmember 752 and the first attachment member 706 can be secured to thestruts 712 at the same time and with the same fasteners (e.g., sutures762). For example, in some embodiments, after securing the commissuretabs 754 of two adjacent leaflets 716 to the first attachment member, atop portion of the first attachment member 706 can be initially securedto an upper strut 712 of the cell 708 with a first suture 762 a (FIG.35D). The second attachment member 752, with the marker 750 securedthereto, can then be aligned with the first attachment member 706 (FIGS.35D and 35E). The first suture 762 a can then be passed through both thefirst attachment member 706 and the second attachment member 752 andaround the struts 712 on a first side of the cell 708 (FIGS. 35D-35G),thereby forming a single load bearing stitch line from the top to thebottom of the cell 708. Similarly, a second suture 762 b can be passedthrough both the first attachment member 706 and the second attachmentmember 752 and around the struts 712 on a second side of the cell 708(FIGS. 35E-35G), thereby forming another single load bearing stitch linefrom the top to the bottom of the cell 708.

In this way, the second attachment member 752 is arranged outside of thefirst attachment member 706 relative to an outer surface of the frame710 and the central longitudinal axis 760 of the frame 710 (FIG. 35C).As a result, metal-on-frame contact between the marker 750 and the frame710 and/or any abrasive contact between the marker 750 and an outside(e.g., outer surface) of the frame 710 can be avoided. Further, bysecuring the marker 750 to the outer, second attachment member 752,contact between the marker 750 and the leaflets (which are secured tothe inner, first attachment member 706) is also avoided.

In some embodiments, the marker 750 can be secured to the struts 712with a sewing pattern that avoids the tissue of the leaflets 716. Insome embodiments, the additional material provided by the secondattachment member 752 can also protect knot tails and sutures used tosecure commissure tabs 754 to the first attachment member 706, therebymaking the commissure more robust and durable.

As described above, due to its positioning on the frame 710 and itsradiopaque nature, the marker 750 can provide identification (e.g.,visibility) of the commissure during an implantation procedure, therebyenabling a desired commissure alignment, as described herein. Further,such a radiopaque marker 750 can also provide identification of alocation of the commissure of the prosthetic valve, followingimplantation and during any future interventional procedures.

FIGS. 35J-35P show additional embodiments of radiopaque markersconfigured to be attached to a commissure within a cell 708 of aprosthetic valve, attached to an additional attachment member which isthen attached to the cell 708, or attached to an additional skirt orfabric material, directly below a location of a commissure (e.g., asshown in FIG. 35L). For example, in some embodiments, any of the markersshown in FIGS. 35J-35P can replace the marker 700 on the prostheticvalve 704 (FIGS. 35A-35B) or the marker 750 on the second attachmentmember 752 (FIGS. 35C-H). Further, any of the markers shown in FIGS.35A-35P can be attached to an additional skirt or fabric material,directly and/or axially below the location of the commissure (as shownin FIG. 35L).

The exemplary markers shown in FIGS. 35J-35P have different shapes orconfigurations.

In some embodiments, a shape of the marker and/or a mounting location onthe valve for the marker can be selected based on a geometry and spacerestrictions of the valve (e.g., size of cells of the frame). In certainembodiments, one or more of the markers shown in FIGS. 35J-35P can beshaped and sized to fit within the cell 708, both when the frame 710 ofthe prosthetic valve is in its radially compressed and radially expandedconfigurations.

FIG. 35J shows an exemplary embodiment of a radiopaque marker 766secured to the attachment member 706 arranged across the cell 708 of theframe 710 with one or more fasteners (e.g., sutures) 768. As shown inFIG. 35J, the marker 766 is arc-shaped, with its longest dimensionarranged in the circumferential direction (e.g., across a width of thecell 708). However, in alternate embodiments, the marker 766 can beoriented differently within the cell 708, such as with its longestdimension in the axial direction (e.g., as shown in FIG. 35L, asdescribed below).

FIG. 35K shows an exemplary embodiment of a radiopaque marker 770secured to the attachment member 706 arranged across the cell 708 of theframe 710 with one or more fasteners (e.g., sutures) 772. The marker 770is annular or “o”-shaped. For example, the marker 770 can include acentral aperture 771 and the one or more fasteners 772 can extendthrough the central aperture 771, around the marker 770, and through thematerial of the attachment member 706. In some embodiments, the marker770 can be centered on the attachment member 706.

FIG. 35L shows an exemplary embodiment of a radiopaque marker 774secured to the attachment member 706 arranged across the cell 708 of theframe 710 with one or more fasteners (e.g., sutures) 775 and aradiopaque marker 776 secured to one or more skirts 778 that extendacross an inner surface of the frame 710 with one or more fasteners(e.g., sutures) 780. In some embodiments, the one or more skirts 778 caninclude a plurality of skirts 778, each secured to a cusp edge ofcorresponding leaflet 716 and folded over to extend across struts 712 ofthe frame 710 disposed between cusp edges of adjacent leaflets 716.Thus, in some embodiments, the marker 776 can be secured to anoverlapping portion 782 of two adjacent skirts 778 which is disposedaxially below the commissure 702. In certain embodiments, the prostheticvalve 704 may have only one of the markers 774 and 776 secured to theframe 710. As shown in the embodiment of FIG. 35L, the markers 774 and776 are arranged to extend in a direction of the central longitudinalaxis 760 of the frame 710 of the prosthetic valve 704 (e.g., the longestdimension of the marker 774 and the marker 776 extends in the axialdirection, relative to the central longitudinal axis 760. The marker 774can be the same or similar to the marker 766 shown in FIG. 35J, butrotated such that its longest dimension extends in the axial direction.

Each of the markers 766, 770, 774, and 776 (FIGS. 35J-35L) can includeone or more mounting apertures 784 configured to receive one or morefasteners (e.g., fasteners 768, 772, 775, or 780) for securing themarker to the attachment member 706 or the one or more skirts 778. Asshown in FIGS. 35J-35L, the mounting apertures 784 can be circular.However, in alternate embodiments, the mounting apertures 784 can have adifferent shape (e.g., oblong, rectangular, triangular, or the like)and/or size (e.g., a diameter or width smaller than a width of themarker).

FIGS. 35M-35P show additional exemplary embodiments of radiopaquemarkers that are reflection asymmetric along an axis that is parallel tothe central longitudinal axis of the frame 710 of the prosthetic valve704. As a result, the markers shown in FIGS. 35M-35P can provide anindication of a position of the commissure 702, relative to a guidewire(as explained herein), under fluoroscopic imaging.

For example, FIG. 35M shows an exemplary embodiment of a radiopaquemarker 786 secured to the attachment member 706 arranged across the cell708 of the frame 710 with one or more fasteners (e.g., sutures) 787. Themarker 786 comprises an elongate cut-out or aperture 789 disposed on afirst side of the marker 786 (relative to a central longitudinal axis790 of the marker 786). Thus, on an opposite, second side of the marker786 (across the axis 790), the marker 786 comprises a solid materialportion 791. The one or more fasteners 780 extend through the aperture789, around the marker 786, and into the attachment member 706. Sincethe solid material portion 791 and the aperture 789 are disposed onopposite sides of the marker 786, relative to the axis 790, the marker786 is reflection asymmetric across the axis 790.

FIG. 35N shows another exemplary embodiment of a radiopaque marker 792secured to the attachment member 706 arranged across the cell 708 of theframe 710 with one or more fasteners (e.g., sutures) 787 and isconfigured similar to marker 786 (FIG. 35M). For example, marker 792also includes an aperture 789 disposed across the axis 790 of the marker792 from the solid material portion 791. However, the aperture 789 andsolid material portion 791 of marker 792 are shaped differently (e.g.,elongated further) than marker 786.

In certain embodiments, the markers described above can be secured tothe attachment member 706, in a region of or to the tissue of theleaflets (e.g., the commissure tabs 754 of the leaflets 716, as shown inFIG. 35H). For example, the underling commissure tabs of the leaflets716 of the commissure 702 are represented in the figures as a moreheavily cross-hatched, central region, on the attachment member 706. Insome embodiments, the markers can be configured to attach to theattachment member 706, outside of this tissue region, thereby avoidingplacing additional fasteners or sutures into the tissue of thecommissure tabs of the leaflets.

FIGS. 35O and 35P show exemplary embodiments of radiopaque markers thatare secured to an additional attachment member (e.g., which can becloth) and the additional attachment member is then secured to theattachment member 706, outside of the underlying tissue region 799. Forexample, FIG. 35O shows an exemplary embodiment of a radiopaque marker794 secured to an additional attachment member 793 by one or morefasteners (e.g., sutures) 797 that can extend through a central aperture(or cut-out region) 795 in the marker 794.

The additional attachment member 793 can be secured directly to theattachment member 706, outside of the tissue region 799, by one or morefasteners (e.g., sutures) 796. As a result, the marker 794 can besecured to the attachment member 706, through the additional attachmentmember 793, without securing the marker 794 itself directly to theattachment member 706.

Similarly, FIG. 35P shows another exemplary embodiment of the radiopaquemarker 794 secured to an additional attachment member 798 by one or morefasteners (e.g., sutures) 797 that can extend through the centralaperture (or cut-out region) 795 in the marker 794. The additionalattachment member 798 can then be secured directly to the attachmentmember 706 by the one or more fasteners 796. As shown in FIGS. 35O and35P, the additional attachment member 798 has a diamond shape while theadditional attachment member 793 has a rectangular shape. Alternateshapes for the additional attachment members are possible (e.g.,circular, square, and the like).

Exemplary methods for attaching a radiopaque marker 750 (or any of theother radiopaque markers described herein) to an attachment memberconfigured to be attached to commissure tabs of two adjacent leaflets(thereby forming a commissure) and secured to struts 712 of a cell 708of a frame 710 of a prosthetic heart valve, such as is shown in FIGS.35A and 35B, are presented in FIGS. 97-101E.

FIGS. 97-99B show one embodiment where a radiopaque marker 750 isattached (e.g., sewn) directly to an attachment member 730. As shown inFIG. 97 , the attachment member 730 can comprise first and second sideportions 732 a, 732 b projecting laterally from a central portion 734(or central region). The attachment member 730 can further comprise anupper tab 736 and a lower tab 738 projecting from upper and lower edges,respectively, of the central portion 734. Further details on attachmentmembers for securing commissure tabs of adjacent leaflets to a cell of aframe of a prosthetic valve are described in U.S. Patent Publication No.2018/0028310, which is incorporated by reference herein.

As shown in FIG. 97 , the marker 750 is secured directly to the centralportion 734 of the attachment member 730 by one or more sutures 740(forming one or more knots on an outside of the marker 750). Theattachment member 730 can then be folded and secured to the commissuretabs of the leaflets such that the marker 750 is either disposed on aradially outward facing surface 742 (e.g., facing away from theleaflets) of the attachment member 730 (FIGS. 98A and 98B) or a radiallyinward facing surface (e.g., the surface disposed opposite the radiallyoutward facing surface 742 and which faces the commissure tabs of theleaflets) of the attachment member 730 (FIGS. 99A and 99B). For example,when the marker 750 is secured to the radially outward facing surface742 of the attachment member 730, when secured to the cell 708, themarker 750 faces outward and away from the leaflets and interior of theframe 710 (FIG. 98B).

In contrast, when the marker 750 is secured to the radially inwardfacing surface of the attachment member 730, when secured to the cell708, the marker 750 faces inward, toward the leaflets (FIG. 99B). Thus,as shown in FIGS. 99A and 99B, the marker 750 is disposed behind theattachment member 730.

FIGS. 100-101E show another embodiment where a radiopaque marker 750 isattached (e.g., sewn) to an elongate flap 744 (or extension) of anattachment member 746. As shown in FIG. 100 , the attachment member 746is similar to the attachment member 730 of FIG. 97 except it comprisesthe longer flap 744 (instead of shorter upper tab 736) extending fromthe central portion 734. As shown in FIGS. 101A-E, the marker 750 can beattached to the flap 744 and the commissure formed with the attachmentmember 746 (such as the commissure 702 shown in FIGS. 32A and 32B) byone or more sutures (or other, similar fasteners) that are used tosecure the commissure tabs of the adjacent leaflets to the attachmentmember 746 (such as shown in FIG. 35H).

For example, the marker 750 can be placed on a first surface 748 of theflap 744 (FIG. 100 , which shows the marker 750 as transparent for thesake of illustration), over one or more apertures in the flap 744. Inthe embodiment of FIGS. 100-101E, the flap 744 includes two apertures,including a first aperture 701 and second aperture 703, which can bespaced apart based on a spacing between the first aperture 726 and thesecond aperture 728 of the marker 750 (e.g., such that the firstaperture 726 overlaps the first aperture 701 and the second aperture 728overlaps the second aperture 703).

The flap 744 can then be folded over an outer surface 705 of the centralportion 734 of the attachment member 746, over sutures extending outwardfrom the outer surface 705 which were used to connect the commissuretabs of the adjacent leaflets to the attachment member 746 (FIG. 101A).As such, the marker 750 is sandwiched between a second (outer) surface707 of the flap 744 and the outer surface 705 of the central portion 734of the attachment member 746 (FIG. 101A).

First sutures 709 can then be routed through the second aperture 728 ofthe marker 750 and through the second aperture 703 in the flap 744 suchthey extend outward and away from the second surface 707 of the flap 744(FIG. 101B). Similarly, second sutures 711 can be routed through thefirst aperture 726 of the marker 750 and through the first aperture 701in the flap 744 such they extend outward and away from the secondsurface 707 of the flap 744 (FIG. 101B).

In some embodiments, free ends of the first sutures 709 can be routedthrough looped portions 713 of the first sutures 709 that are arrangedon each side of the flap 744, beneath the flap 744 (FIG. 101C). Thefirst sutures 709 are then tightened against the flap 744, as shown inFIG. 101D.

The free (loose) ends of the first sutures 709 can then be tied (orknotted) together to secure a first portion (top portion in the view ofFIGS. 101A-101E) of the marker 750 to the attachment member 746 and thefree (loose) ends of each second sutures 711 can then be tied (orknotted) together with a corresponding third suture 717 (of a pair ofthird sutures 717 arranged beneath the flap 744) to secure a second(e.g., bottom) portion of the marker 750 to the attachment member 746(FIG. 101E).

In some embodiments, the first sutures 709 can be tied into one singleand one double knot, thereby forming a first knotted portion 715 (FIG.101E). Each second suture 711 can be tied into one single and two doubleknots with the corresponding third suture 717, thereby forming a secondknotted portion 719 and a third knotted portion 721 on opposite sides ofthe first aperture 701 (FIG. 101E).

In this way, the marker 750 can be secured to the flap 744 of theattachment member 746 with the same sutures (or similar fixationmembers) that were used to secure the commissure tabs of the adjacentleaflets to an inner surface of the attachment member 746. This cansimplify the assembly process of the prosthetic heart valve, therebysaving time and assembly costs.

As introduced above, a prosthetic valve can be mounted around andradially compressed (e.g., crimped) onto a valve mounting portion of adistal end portion of a delivery apparatus (e.g., valve mounting portion324 of delivery apparatus 300 shown in FIGS. 9-11 and 32A-32B), fordelivery of the valve to the target implantation site (e.g., a nativevalve of the heart). In some embodiments, an inflatable balloon of thedelivery apparatus (e.g., balloon 318 shown in FIGS. 9-11 and 32A-32B)is pleated and wrapped in a manner that more efficiently folds theballoon material in order to minimize the folded balloon diameter. As aresult, a diameter of the prosthetic valve, which is crimped in theradially compressed configuration onto the folded balloon, may also beminimized.

FIG. 36 shows an embodiment of an inflatable balloon 818 folded around adistal end portion 809 of a delivery apparatus 800. The deliveryapparatus 800 may be similar to delivery apparatus 300 of FIGS. 9-11 andincludes one or more shoulders 802 mounted on an inner shaft 808, theinner shaft extending distally from an intermediate (e.g., balloon)shaft 806. The balloon 818 overlays a valve mounting portion 824 of thedistal end portion 809 of the delivery apparatus 800. The portion of theballoon 818 at the valve mounting portion 824 can include one or moreaxially extending folds or pleats 830. Such axial pleats 830 can betightly compressed in order to minimize the profile of the balloon 818and the prosthetic heart valve crimped thereon.

In some embodiments, a distal portion 832 of the balloon 818 can includeone or more axial folds or pleats 834 when the balloon 818 is in adeflated state ready for insertion into a patient's vasculature. In someembodiments, a proximal portion 836 of the balloon 818 can include oneor more axial folds or pleats 838 when the balloon is in a deflatedstate ready for insertion into a patient's vasculature. The axial pleats834, 838 can reduce the overall profile of the distal end portion 809 ofthe delivery apparatus 800 to facilitate passage of the deliveryapparatus 800 through the introducer sheath and the patient'svasculature. Further details on the folding or wrapping of a balloon ona distal end portion of a delivery apparatus is described in U.S.Provisional Application No. 63/051,244, filed Jul. 13, 2020, which isincorporated by reference herein.

In some embodiments, the balloon 318 of delivery apparatus 300 shown inFIGS. 9-11, 28, and 32A-32B can be folded similarly to that of balloon818, as described above. FIG. 37 is an exemplary, cross-sectional viewof the balloon 318 of delivery apparatus 300, wrapped and folded aroundthe inner shaft 308, at the valve mounting portion 324 of the deliveryapparatus 300. As shown in FIG. 37 , the balloon 318 includes aplurality of overlapping pleats or folds 390 when in its deflatedconfiguration and when a prosthetic valve is mounted on and radiallycompressed around the balloon 318. The balloon 318 can be folded in sucha way that the pleats 390 result in a minimized folded balloon diameter(e.g., in its deflated configuration) which can reduce a diameter of theradially compressed prosthetic valve when crimped thereon.

As introduced above with reference to FIGS. 9-11 , the distal endportion 309 of the delivery apparatus 300 can include a distal tipportion 328 mounted on the distal end of the outer shaft 304. Fordelivery of the prosthetic valve to the target implantation site, theouter shaft 304 and the intermediate shaft (e.g., balloon shaft) 306 canbe moved axially relative to one another such that the distal tipportion 328 is arranged over a proximal end portion of the balloon 318(e.g., proximal end portion 333, as shown in FIG. 10 ). As a result, thedistal tip portion 328 can act as a proximal shoulder on a proximal sideof the valve mounting portion 324 and resist movement of the radiallycompressed prosthetic valve, proximally in the axial direction, duringadvancing the distal end portion of the delivery apparatus to the targetimplantation site. For example, in some embodiments, the intermediateshaft 306 can be pulled into the outer shaft 304 or the outer shaft 304can be pushed over the intermediate shaft 306, thereby moving theproximal end portion of the balloon 318 into an interior of the distaltip portion 328. In some embodiments, the distal tip portion 328 caninclude internal and/or external expansion cuts or grooves that provideflexibility to the distal tip portion 328 and allow it to expandradially outward as it moves over the proximal end portion of theballoon 318, thereby increasing its ability to act as a balloon shoulderand resist axial movement of the radially compressed prosthetic valvemounted around the balloon 318 at the valve mounting portion 324.

In some embodiments, the expansion cuts of the distal tip portionarranged along an interior surface of the distal tip portion can extendaxially along the interior surface (relative to the central longitudinalaxis of the delivery apparatus). However, these axially extendingexpansion cuts can cause issues when rotating the balloon shaft (e.g.,intermediate shaft 306) to which the balloon 318 is mounted (since theballoon 318 rotates as a result of the balloon shaft rotating), whenrotationally aligning the distal end portion of the delivery apparatusat the target implantation site, as described herein. For example,during rotating the balloon or intermediate shaft, pleats of the foldedballoon 318 (as described above with reference to FIGS. 36 and 37 ) canget stuck in the axially extending, interior expansion cuts of thedistal tip portion. Examples of such axially extending expansion cutscan be found in U.S. Pat. No. 9,061,119, which is incorporated byreference herein.

Thus, it may be desirable to have a distal tip portion that isconfigured to radially expand over the proximal end portion of theballoon 318, while also allowing the balloon 318 to slide more easilywithin the distal tip portion, without the pleats of the balloon gettingstuck, when rotating the intermediate shaft of the delivery apparatus

FIGS. 38-41 show an embodiment of the distal end portion 309 of thedelivery apparatus where the outer shaft 304 includes a distal tipportion 900 mounted on the distal end of the outer shaft 304 and theballoon 318 includes the radial depression 334 (FIGS. 40 and 41 ) incertain configurations. In some embodiments, the distal tip portion 900can be the distal tip portion 328 of FIGS. 9 and 11 .

The distal tip portion 900 can be configured as a flex adaptor includinga flex portion 912 and a coupling portion (also can be referred to as astraight portion) 914. The flex portion 912 can extend from a distal endof the coupling portion 914 and be configured to flex (e.g., expandradially outward) from the distal end of the coupling portion 914. Thecoupling portion 914 can be coupled to and mounted around the distal endof the outer shaft 304 (FIG. 39 ).

The flex portion 912 can be tapered and have an outer diameter thanincreases in a distal direction, from the distal end of the couplingportion 914 to a distal end of the flex portion 912.

The flex portion 912 can include a plurality of internal expansion cutsor grooves 902 (also referred to herein as helical internal grooves) anda plurality of external expansion cuts or grooves 904 (also referred toherein as helical external grooves) (FIGS. 38, 39, and 41 ). As shown inFIGS. 38 and 39 , the internal expansion grooves 902 are helical andcurve around a central longitudinal axis 906, from a proximal end 908 ofthe flex portion 912 (e.g., where the flex portion 912 extends from thecoupling portion 914) to a distal end 910 of the distal tip portion 900.The external expansion grooves 904 can also be helical and curve aroundthe central longitudinal axis 906, from the proximal end 908 of the flexportion 912 to the distal end 910 of the distal tip portion 900.

In some embodiments, each groove of the internal expansion grooves 902can curve from about 75 to about 110 degrees, from about 80 to about 100degrees, or from about 85 to about 95 degrees around the centrallongitudinal axis 906. In some embodiments, each groove of the externalexpansion grooves 904 can curve from about 75 to about 110 degrees, fromabout 80 to about 100 degrees, or from about 85 to about 95 degreesaround the central longitudinal axis 906.

In some embodiments, the internal expansion grooves 902 are spaced apartfrom one another and the external expansion grooves 904 are spaced apartfrom one another, around a circumference of the distal tip portion 900.

In some embodiments, the internal expansion grooves 902 are offset(e.g., circumferentially offset) from the external expansion grooves 904such that a location where one external expansion groove 904 depressesinto an outer surface of the distal tip portion 900 is arranged betweenwhere two adjacent grooves of the internal expansion grooves 902 depressinto an inner surface of the distal tip portion 900 (FIG. 38 ).

The internal expansion grooves 902 and the external expansion grooves904 are configured to allow the flex portion 912 to flex radiallyoutward as the distal tip portion 900 is moved over a proximal endportion 333 of the balloon 318 (FIG. 40 ), toward the valve mountingportion 324. FIG. 41 shows the distal tip portion 900 arranged over theproximal end portion 333 of the balloon 318, during advancing a radiallycompressed prosthetic valve 922 (which can be similar to one of theprosthetic valves described herein), mounted on the valve mountingportion 324 of the delivery apparatus, through a patient's vasculatureand to the target implantation site.

The helical shape and orientation of the internal expansion grooves 902can be configured such that during rotating the intermediate (balloon)shaft 306 (e.g., to achieve commissure alignment at the targetimplantation site, as described herein), engagement between the pleatsof the balloon 318 (e.g., pleats or folds 390 shown in FIG. 37 ) and theinternal expansion grooves 902 is reduced, thereby allowing the balloon318 to slide more easily along the inner surface of the distal tipportion 900 while the balloon 318 rotates within the distal tip portion900. For example, the helical shape and orientation of the internalexpansion grooves 902 can prevent the pleats of the balloon 318 fromdiving into and getting caught within the internal expansion grooves902, as the intermediate shaft 306, and thus the balloon 318, isrotated.

Following crimping of the prosthetic valve onto the valve mountingportion 324 and advancing the distal tip portion 900 over the proximalend portion 333 of the balloon 318 (as shown in FIG. 41 ), fluidarranged within the proximal end portion 333 of the balloon 318 isdisplaced and pushed distally within the balloon 318. As a result, thedistal end portion 332 of the balloon 318 can expand radially outwardexcessively and can cause the crimped profile (e.g., diameter) of theprosthetic valve 922 to increase. An increased crimped valve profile canresult in increased resistance when pushing the delivery apparatus intoand through a loader and sheath of a delivery assembly.

Thus, in order to reduce or prevent the increase in the crimped profileof the prosthetic valve 922, the distal end portion 332 of the balloon318 can be formed with a radial depression 334 that is depressed inward,toward the central longitudinal axis 320 of the delivery apparatus(FIGS. 40 and 41 ). In some embodiments, the radial depression 334 canbe depressed inward, relative to an outermost radial surface of thedistal shoulder 326. For example, as shown in FIG. 40 , the distal endportion 332 of the balloon 318 can extend over a wider, flared portion331 (e.g., which can be formed by wings 330) of the distal shoulder 326,then depress radially inward, toward the base portion 325 of the distalshoulder 326, and then extend back radially outward to a proximal end ofthe nose cone 322, thereby forming the radial depression. FIG. 40 showsa state of the balloon 318, including the radial depression 334 in thedistal end portion 332, prior to crimping the prosthetic valve onto thevalve mounting portion 324 and advancing the distal tip portion 900 overthe proximal end portion 333 of the balloon 318.

After crimping of the prosthetic valve onto the valve mounting portion324 and advancing the distal tip portion 900 over the proximal endportion 333 of the balloon 318 (as shown in FIG. 41 ), fluid arrangedwithin the proximal end portion 333 of the balloon 318 is displaced andpushed distally, within the balloon 318, to the distal end portion 332of the balloon 318. The radially depressed, distal end portion 332 ofthe balloon 318 can then radially expand (e.g., inflate partially) as itreceives the displaced fluid to the expanded state 924 shown in FIG. 41(solid lines) and FIG. 26 (dashed lines). The radial depression 334 canbe configured (e.g., sized) so that the distal end portion 332 canreceive the displaced fluid without radial expanding the portion of theballoon 318 within the valve mounting portion 324, thereby preventingthe crimped profile of the prosthetic valve 922 from increasing.

Prior to inflating the balloon 318 to deploy the prosthetic valve 922 atthe target implantation site, the distal tip portion 900 can be movedaxially away from the prosthetic valve 922 and off the balloon 318(either by pulling the outer shaft 304 proximally relative to theintermediate shaft 306 or by pushing the intermediate shaft 306 distallyrelative to the outer shaft 304). The prosthetic valve 922 can then bedeployed and radially expanded by inflating the balloon 918.

When the balloon 318 is inflated (e.g., when the distal end portion ofthe delivery apparatus and the prosthetic valve have reached the targetimplantation site, such as the native valve), the balloon 318 unfurls(e.g., unwraps) into its expanded state, thereby radially expanding theprosthetic valve to its radially expanded state. As the balloon 318expands, and its folds or pleats 390 unwrap (FIG. 37 ), the prostheticvalve radially expands and rotates by a predetermined (e.g., known)amount. For example, the unfolding of the pleats 390 of the ballooncauses the prosthetic valve to rotate during the balloon inflation. Assuch, the position of the radially expanded prosthetic valve is rotatedfrom its position on the delivery apparatus prior to inflating theballoon 318, by the predetermined amount (e.g., 10°, 20°, 30°, or thelike). In some embodiments, during manufacturing of the deliveryapparatus, the balloon can be wrapped and/or folded in a consistentand/or standardized manner such that a consistent amount of rotation ofthe prosthetic valve occurs during valve deployment (e.g., for aplurality of delivery apparatuses manufactured in a same way).

Thus, it may be desirable to mount (e.g., crimp) the prosthetic valveinto its radially compressed state onto the valve mounting portion ofthe delivery apparatus such that a selected commissure of the prostheticvalve is offset from the marker (e.g., marker 500 of FIG. 28 , marker600 of FIGS. 30-32B, or marker 650 of FIGS. 33-34B) on the deliveryapparatus by the predetermined amount, or is at least based on thepredetermined amount of rotation. In this way, the circumferentialoffset between the marker and the selected commissure of the prostheticvalve can compensate for the valve rotation that occurs during inflationof the balloon and valve deployment. In some embodiments, thepredetermined amount of offset can be at least partially based on theballoon wrapping and resulting amount of rotation of the valve thatoccurs during inflation of the balloon.

For example, deploying the prosthetic valve by inflating the balloon,after aligning the marker on the delivery apparatus with the guidewirewithin a selected imaging view (e.g., aligning the asymmetric markerwith the guidewire such that the marker is arranged at the back of theselected imaging view), may cause the prosthetic valve to rotate andimplant within the native valve with commissures of the prosthetic valvein alignment with commissures of the native valve (as described infurther detail below). In some embodiments, the marker on the deliveryapparatus can be configured to indicate a circumferential location of aselected commissure of the prosthetic valve after valve deployment.

FIG. 42 shows an example of the prosthetic valve 922 mounted on andaround the valve mounting portion 324 of the distal end portion 309 ofthe delivery apparatus 300, in a radially compressed state, with aselected commissure (indicated by a dashed line in FIG. 42 ) 930circumferentially offset from the marker 600 by a predetermined amount932. As discussed above, upon deployment of the prosthetic valve 922 viainflating the balloon, the prosthetic valve 922 can rotate as itradially expands, by the predetermined amount 932, such that theselected commissure at 930 ends up be circumferentially aligned with themarker 600. As a result, the selected commissure at 930 of the implantedprosthetic valve can be aligned with a selected commissure of the nativevalve.

In alternate embodiments, the predetermined amount 932 of offset can bedifferent from the predetermined amount of inflation of the prostheticvalve upon deployment via inflating the balloon. For example, asdescribed further below, the predetermined amount of offset can bedetermined based on a desired imaging view selected for viewing thedelivery apparatus in a heart during an implantation procedure (e.g.,based on a known location of the target commissure of the native valvewithin the selected imaging view). In some embodiments, thepredetermined amount of offset can be determined based on both theselected imaging view and the predetermined amount of rotation of theprosthetic valve upon deployment.

In order to mount and crimp the prosthetic valve onto the valve mountingportion of the delivery apparatus at a predetermined position and/ororientation (e.g., circumferential position and/or orientation) relativeto the delivery apparatus (e.g., relative to the radiopaque marker onthe distal shoulder or another portion of the distal end portion of thedelivery apparatus), a mounting assembly can be used. The mountingassembly can include a first component configured to interface with anuncrimped (e.g., at least partially radially expanded) prosthetic valveand a second component configured to interface with a portion of thedistal end portion of the delivery apparatus (e.g., a portion disposedproximal and/or adjacent to the valve mounting portion). The first andsecond components of the mounting assembly can be further configured tointerface with different sides of a crimping device. As a result, themounting assembly can hold the prosthetic valve at a predeterminedorientation and/or predetermined position relative to the deliveryapparatus within the crimper. Then, after crimping the prosthetic valveonto the valve mounting portion of the delivery apparatus, theprosthetic valve can be arranged in the radially compressedconfiguration, in a predetermined position and orientation relative tothe delivery apparatus. For example, the radially compressed prostheticvalve can be arranged on the delivery apparatus such that a selectedcommissure of the prosthetic valve is circumferentially offset from themarker (or other desired landmark) on the delivery apparatus by thepredetermined amount (e.g., as shown in FIG. 42 ).

FIGS. 43-52 show embodiments of various components that can be used in amounting assembly configured to crimp a prosthetic valve (such as one ofthe prosthetic valves described herein) onto a valve mounting portion ofa delivery apparatus (e.g., valve mounting portion 324 of deliveryapparatus 300) in a predetermined position and orientation. Theprosthetic valve may be crimped to the valve mounting portion of thedelivery apparatus in a variety of manners. In some embodiments, acrimping device, such as the crimping device 1084 shown in FIGS. 43 and44 , can be used to crimp the prosthetic valve onto the valve mountingportion of the delivery apparatus. As described further below, thecrimping device 1084 can include mating interfaces, on opposite sides ofthe crimping device 1084, that are configured to receive and mate withcorresponding mating interfaces on first and second components of themounting assembly.

FIG. 43 illustrates a rear perspective view of the crimping device 1084(or a view from the proximal side of the crimping device 1084) and FIG.44 illustrates a front perspective view of the crimping device 1084 (ora view from the distal side of the crimping device 1084). The crimpingdevice 1084 can include a base 1086, an actuator in the form of a handle1088, and a channel 1090 for the prosthetic valve and the deliveryapparatus to be inserted into. The crimping device 1084 may include aproximal face 1092 including a proximal opening 1094 that leads into thechannel 1090. The proximal opening 1094 may be configured for thedelivery apparatus to be inserted into the channel 1090 therethrough.

In some embodiments, the proximal face 1092 can include a matinginterface with mating structures 1096 in the form of cut-outs that canbe configured to mate with a positioning device 1072, for example asshown in FIG. 49 . For example, the mating interface can include one ormore mating structures 1096.

The crimping device 1084 can further include a rotatable body 1098configured to be rotated with rotation of the handle 1088. The crimpingdevice 1084 may operate by a plurality of pressing surfaces 1000surrounding the channel 1090 and being configured to apply a compressiveforce to radially compress a prosthetic valve positioned within thechannel 1090 (e.g., prosthetic valve 922 shown in FIGS. 51 and 52 , asdescribed further below). The pressing surfaces 1000 may surround anaxis 1002 of the channel 1090. The pressing surfaces 1000 may beconfigured such that as the rotatable body 1098 is rotated, a bodypresses and moves the pressing surfaces 1000 towards the center of thechannel 1090 and the diameter of the channel 1090 reduces. The pressingsurfaces 1000 may form an iris structure that allows the pressingsurfaces 1000 to move towards the center of the channel 1090 and reducethe diameter of the channel 1090. A prosthetic valve positioned withinthe channel 1090 will accordingly be compressed within the channel 1090,due to the radially compressive force of the pressing surfaces 1000against the prosthetic valve.

As shown in FIG. 44 , the crimping device 1084 may include a distal face1004 including a distal opening 1006 that leads into the channel 1090.The distal face 1004 can include a mating interface, which can comprisea cut-out portion 1008. In some embodiments, the cut-out portion 1008can be configured as a notch, indentation, depression, or the like, inthe distal face 1004. The cut-out portion 1008 can be configured (e.g.,shaped) to receive an alignment device of a support body for theprosthetic valve (e.g., alignment member 1024 shown in FIG. 45 , asdescribed further below).

The distal opening 1006 can be configured for a portion of the deliveryapparatus to pass therethrough during a crimping operation beingperformed by the crimping device 1084.

The configuration of a crimping device can be varied in alternateembodiments.

For crimping the prosthetic valve onto the valve mounting portion of thedelivery apparatus, it may be desirable to maintain the leaflets (e.g.,leaflets 60 of prosthetic heart valve 50 shown in FIGS. 2A and 2B) in anopen position during crimping of the prosthetic valve to the deliveryapparatus, thereby reducing a likelihood of degradation to the leafletsand/or attachments of the leaflets to a frame of the prosthetic valve.Thus, in some embodiments, a support body that is configured to supportand/or maintain one or more leaflets of the prosthetic valve in an openposition can be used as the first component of a mounting assembly thatis configured to hold the prosthetic valve and position the prostheticvalve within the crimper.

An exemplary support body 1010 is shown in FIG. 45 . The support body1010 can be configured to be inserted into a crimping device, such ascrimping device 1084 shown in FIGS. 43 and 44 , and can have a supportportion 1012 configured to be positioned between one or more leaflets ofthe prosthetic device and the delivery apparatus (e.g., deliveryapparatus 300) and for supporting the one or more leaflets in an openposition. The support body 1010 can comprise the support portion 1012and a coupling portion 1013 configured to be received within and/orcoupled to the crimping device. The support body 1010 can include afirst end 1014 and a second end 1016. The support portion 1012 caninclude an outward-facing support surface 1015 that is configured toreceive the prosthetic valve thereon (e.g., an interface with the valveleaflets).

In some embodiments, as shown in FIG. 45 , the coupling portion 1013 canhave a cylindrical shape with a cylindrical outer surface 1018. Thecoupling portion 1013 can extend from the first end 1014 to a first(e.g., proximally facing) surface 1020 that can be arranged normal to acentral longitudinal axis extending through a center of the support body1010, from the first end 1014 to the second end 1016. The first surface1020 can join the coupling portion 1013 to the support portion 1012,including the support surface 1015. In some embodiments, the firstsurface 1020 can include an alignment element, such as a recess 1022,which can be configured to receive a coupler (e.g., coupling element)1070 of a ring body (also referred to herein as an alignment ring) 1038,as shown in FIGS. 47 and 48 .

An alignment member 1024 can be arranged on the coupling portion 1013and configured to rotationally align the support body 1010 with thecrimping device 1084. The alignment member 1024 can be circumferentiallypositioned on the coupling portion 1013, proximate to the first end1014, at a position that circumferentially aligns the support body 1010in a predetermined position and orientation within the crimping device1084.

In some embodiments, as shown in FIG. 45 , the alignment member 1024 cancomprise an axially extending protrusion that extends axially outwardfrom the first end 1014 toward to the second end 1016 of the supportbody 1010. In other embodiments, the alignment member can have otherconfigurations, such as a recess or other alignment feature that isconfigured to mate with a corresponding mating interface of the crimpingdevice 1084 (e.g., cut-out portion 1008 shown in FIG. 44 ).

For example, the alignment member 1024 can be configured to insert intothe cut-out portion 1008 on the distal face 1004 of the crimping device1084 to rotationally align the support body 1010 with the crimpingdevice 1084. The alignment member 1024 can further be configured toallow the support body 1010 to slide distally out of the cut-out portion1008 during operation of the crimping device 1084.

The support portion 1012 can extend from the first surface 1020 to thesecond end 1016. The support portion 1012 includes the support surface1015. The support portion 1012, and thus the support surface 1015, canhave a tapered shape that tapers radially inward in a direction from thefirst surface 1020 to the second end 1016. For example, a diameter ofthe support portion 1012 can decrease from the first surface 1020 to thesecond end 1016. In some embodiments, the support portion 1012 can havea conical shape, as shown in FIG. 45 . In alternate embodiments, thesupport portion 1012 can have another shape that tapers as describedabove, such as hexagonal or pyramidal.

In some embodiments, the support portion 1012 can have a greatestdiameter that is less than the diameter of the cylindrical couplingportion 1013.

In some embodiments, a connector portion 1026 (FIG. 45 ) can join thesupport surface 1015 to the first surface 1020 and can have an annularshape with a relatively constant diameter.

The support surface 1015 can be configured for interior surfaces of theleaflets of the prosthetic valve to contact and rest upon the supportsurface 1015 when the prosthetic valve is positioned around the supportportion 1012 (as shown in FIG. 50 ). The support surface 1015 can beconfigured to resist the leaflets from moving to a closed position whenthe prosthetic valve is positioned around the support portion 1012 andwithin the crimping device 1084.

The tapered shape of the support portion 1012, as described above, canallow the support body 1010 to be slid distally, away from the crimpingdevice 1084, when the pressing surfaces 1000 of the crimping device 1084press upon the support surface 1015. As such, the tapered shape of thesupport portion 1012 may cause a pressing force applied by the pressingsurfaces 1000 to move proximally along the tapered shape of the supportsurface 1015, thereby moving the support body 1010 distally and out ofthe crimping device 1084. The support surface 1015 can maintain theleaflets in an open position as the pressing surfaces 1000 press againstthe tapered support surface 1015.

In this way, the support body 1010 can be configured to slide axiallyaway from the prosthetic valve during and as a result of the crimpingdevice 1084 crimping the prosthetic valve. The support body 1010, forexample, can be configured to insert into the channel 1090 of thecrimping device 1084 and slide axially away from the channel 1090 uponthe crimping device 1084 crimping the prosthetic valve 922, and thus,may slide in an axially distal direction (as shown in FIG. 52 ).

As shown in FIG. 45 , the support body 1010 can include a centralaperture 1028 leading to a central channel 1030. The central aperture1028 and central channel 1030 may be configured for the deliveryapparatus to extend therethrough. An inner surface of the supportportion 1012 can define the central channel 1030. The central aperture1028 can be positioned at the second end 1016 and the central channel1030 can extend from the second end 1016 to the first end 1014.

In operation, the prosthetic valve 922 may be slid distally onto thesupport surface 1015 of the support portion 1012 of the support body1010, with the frame 940 of the prosthetic valve 922 extending over thesupport surface 1015 and the inner surfaces of the leaflets 942 of theprosthetic valve being arranged against the support surface 1015 (FIGS.50 and 51 ).

To align the prosthetic valve 922 in a desired circumferentialorientation around the support portion 1012, and to space the prostheticvalve 922 from the first surface 1020 at a desired spacing, a ring body(which can also be referred to as an alignment ring) can be utilized andpositioned upon the support body 1010.

FIGS. 46 and 47 , for example, illustrate perspective views, fromdifferent sides, of a ring body 1038 that can be utilized with thesupport body 1010. The ring body 1038 can be configured to couple to andextend around the support body 1010. The ring body 1038 can include afirst surface (which may be a proximally facing surface) 1040 (FIG. 46), a second surface 1042 facing opposite the first surface 1040 (whichmay be a distally facing surface) (FIG. 47 ), and an outer (e.g.,circumferential) surface 1044 facing radially outward and connecting thefirst surface 1040 to the second surface 1042. The ring body 1038 caninclude an inner surface 1046 facing opposite the outer surface 1044 andfacing radially inward, the inner surface 1046 defining a centralchannel (e.g., opening or aperture) 1048 of the ring body 1038.

In some embodiments, an alignment guide can be positioned on the ringbody 1038 (FIG. 46 ). The alignment guide can comprise one or moreindicators 1050 a-c (which may also be referred to as alignment markers)configured to indicate a desired circumferential (e.g., rotational)position of selected elements (e.g., commissures) of the prostheticvalve 922 relative to the ring body 1038 (FIGS. 46, 48, and 50 ). Eachindicator 1050 a-c may further indicate the desired circumferentialposition of the selected elements of the prosthetic valve 922 relativeto the support body 1010 (e.g., when the ring body 1038 is coupled tothe support body 1010, as described further below with reference toFIGS. 48 and 50 ).

Each indicator 1050 a-c can comprise a marking, groove, raised element,or other form of indicator, on one or more of the first surface 1040,the second surface 1042, or the outer surface 1044 of the ring body1038. One or more or each of the indicators 1050 a-c, for example, cancomprise a variation in the surface profile of the ring body 1038, suchas a raised portion or a recessed portion (e.g., groove). The indicators1050 a-c shown in FIGS. 46-48 and 50 , for example, each compriserecessed portions in the form of grooves on the first surface 1040 andextending to the outer surface 1044. In some embodiments, the indicators1050 a-c can additionally be printed upon to vary a color of therespective indicator 1050 a-c such that the indicator is easier tovisualize. In some embodiments, the indicators 1050 a-c may solely beprinted upon the ring body 1038 without use of a variation of thesurface profile (e.g., without grooves).

The indicators 1050 a-c can be circumferentially spaced apart from eachother on the ring body 1038. In some embodiments, the indicators 1050a-c can be equally spaced apart from each other around the circumferenceof the ring body 1038. The circumferential position of each indicator1050 a-c can correspond to and indicate a desired position of one of thecommissures of the prosthetic valve when the ring body 1038 is coupledto the support body 1010 and the prosthetic valve is arranged around thesupport portion 1012 of the support body 1010 (e.g., as shown in FIG. 50). As such, a user may position the ring body 1038 on the support body1010 and align the commissures 944 a-c of the prosthetic valve 922 withrespective indicators 1050 a-c (FIG. 50 ).

In some embodiments, the ring body 1038 can include one or more arms(which can also referred to as body portions) 1052, 1054 each extendingaround and defining the central channel 1048 (FIGS. 46 and 47 ). Eacharm 1052, 1054 can have an arcuate shape forming the ring body 1038.Each arm 1052, 1054 can comprise half of the ring body 1038 or anotheramount as desired.

The first arm 1052 can include a first end portion 1056 (FIG. 46 ) and asecond end portion 1058 (FIG. 47 ), with the first end portion 1056positioned at a pivot 1060 (FIG. 46 ) that couples the first arm 1052 tothe second arm 1054. The second end portion 1058 of the first arm 1052may include a coupler for coupling to the second arm 1054. The secondarm 1054 may include a first end portion 1062 (FIG. 46 ) positioned atthe pivot 1060 and a second end portion 1064 (FIG. 47 ) positioned atthe coupler. The coupler (also can be referred to as a couplinginterface) may comprise a recess in the second end portion 1058 of thefirst arm 1052, and a protrusion at the second end portion 1064 of thesecond arm 1054. The protrusion may extend into the recess and may beheld in position with an interference fit or another form of coupling.As such, the second end portions 1058, 1064 of the respective first arm1052 and second arm 1054 may be configured to couple to each other tohold the ring body 1038 together. If desired, the ring body 1038 may beseparated and removed from the support body 1010 by the second endportions 1058, 1064 being separated from each other and the arms 1052,1054 pivoted about the pivot 1060 to an open position. For example, thering body 1038 can be opened to be removed from the support body 1010and can be closed to be held around and coupled to the support body1010.

As shown in FIGS. 46 and 47 , a first lever (e.g., radial extension)1066 may extend radially outward from the first arm 1052, and a secondlever (e.g., radial extension) 1068 may extend radially outward from thesecond arm 1054. The first lever 1066 and second lever 1068 may each beconfigured to be pressed to rotate the first arm 1052 or the second arm1054 about the pivot 1060 to cause the ring body 1038 to move to theopen position.

The ring body 1038 may have an axial width 1071 that may define aspacing of the prosthetic valve from the first surface 1020 of thesupport body 1010 (FIG. 46 ).

As shown in FIG. 47 , the ring body 1038 can include a coupler 1070extending axially outward from the second surface 1042. In someembodiments, the coupler 1070 can be a protrusion configured to extendinto the recess 1022 of the support body 1010 (FIG. 45 ). In alternateembodiments, the coupler 1070 can be a differently shaped mating featureconfigured to mate with a corresponding feature on the support body1010.

The coupler 1070 may be circumferentially positioned relative to therecess 1022 such that the ring body 1038 mates with the support body1010 at a desired circumferential alignment. In this way, the coupler1070 and the recess 1022 may rotationally align the ring body 1038 withthe support body 1010 so that the prosthetic valve is circumferentiallyaligned in a desired orientation relative to the support body 1010 andcrimping device.

In operation, the ring body 1038 can be positioned upon and/or aroundthe support body 1010, with the indicators 1050 a-c positioned at adesired rotational (e.g., circumferential) alignment relative to thesupport body 1010 (FIG. 48 ). The coupler 1070 shown in FIG. 47 , forexample, can be received within the recess 1022, therebycircumferentially aligning the ring body 1038 at a desired positionrelative to the support body 1010. In other embodiments, other alignmentdevices may be utilized to rotationally align the ring body 1038 withrespect to the support body 1010 in the desired rotational alignment.

The ring body 1038 can abut the first surface 1020 of the support body1010. The ring body 1038 can be configured to abut the prosthetic valve922 when the prosthetic valve 922 is positioned on the support body1010. As such, the prosthetic valve 922 may be positioned on the supportsurface 1015 with an end of the prosthetic valve 922 abutting the firstsurface 1040 of the ring body 1038 and defining a position of theprosthetic valve 922 upon the support surface 1015. The ring body 1038accordingly may comprise a spacer configured to define a position of theprosthetic valve 922 upon the support body 1010.

In some embodiments, the ring body 1038 can be oriented in an openconfiguration with the arms 1052, 1054 open and then may be positionedon and around the support body 1010 with the arms 1052, 1054 closed tosecure the ring body 1038 around the support body 1010. The ring body1038 may be positioned upon the connector portion 1026 shown in FIG. 45, for example.

The prosthetic valve 922 may then be positioned around the supportportion 1012 and the support surface 1015, and abutted against the firstsurface 1040 of the ring body 1038. The prosthetic valve 922 may bepositioned upon the support surface 1015 with the commissures 944 a-ccircumferentially aligned with the indicators 1050 a-c and an end of theprosthetic valve 922 abutting the first surface 1040 (FIG. 50 ).

The use of the ring body 1038 may allow the commissures 944 a-c of theprosthetic valve 922 to be positioned in a desired circumferentialorientation relative to the ring body 1038 and thus relative to thesupport body 1010 (e.g., relative to the alignment member 1024 of thesupport body 1010). The alignment member 1024 can then rotationallyalign the support body 1010 with the crimping device 1084, and thusplace the commissures 944 a-c of the prosthetic valve 922 in a desiredrotational orientation within the crimping device 1084.

As a result, the prosthetic valve 922 can be crimped onto the deliveryapparatus at a predetermined circumferential orientation relative to thedelivery apparatus (e.g., relative to a radiopaque marker on thedelivery apparatus, as described herein).

The support body 1010 and the ring body 1038 may each be part of anassembly or system (e.g., mounting assembly) for use in crimping aprosthetic valve having one or more leaflets to a delivery apparatus. Insome embodiments, the assemblies or systems may include a positioningdevice 1072 configured to couple to a portion (e.g., distal end portion)of the delivery apparatus, proximal to the valve mounting portion. FIG.49 , for example, illustrates an embodiment of such a positioning device1072 positioned proximal of the valve mounting portion 324. Thepositioning device 1072 includes a body 1074 including a first portion1076 and a second portion 1078 joined at a hinge 1080. The body 1074 caninclude a central channel 1082 that an intermediate shaft 306 (oranother shaft portion, such as the outer shaft 304) of the deliveryapparatus may be positioned in, with the second portion 1078 rotatingabout the hinge 1080 to close the central channel 1082 and retain thedelivery apparatus (e.g. the intermediate shaft 306) within the centralchannel 1082.

The body 1074 may further include a flange portion 1053 including one ormore mating surfaces (e.g., interfaces) in the forms of flanges 1051(FIG. 49 ) that are configured to engage the mating structures 1096 ofthe proximal face 1092 of the crimping device 1084 (FIG. 43 ).

The positioning device 1072 may be utilized to couple to the distal endportion 309 of the delivery apparatus and suspend the distal end portion309 of the delivery apparatus in position within the channel 1090 of thecrimping device 1084 (FIGS. 51 and 52 ). The positioning device 1072accordingly may hold the delivery apparatus spaced from the pressingsurfaces 1000 of the crimping device 1084, as shown in FIG. 51 forexample.

Further, the positioning device 1072 may be positioned axially along thedelivery apparatus such that the valve mounting portion 324 is heldwithin a defined axial position within the channel 1090 of the crimpingdevice 1084. In some embodiments, such a feature may further allow thedistal shoulder 326 of the delivery apparatus to be positioned outsideof the channel 1090 of the crimping device 1084 and distal of thechannel 1090 such that the distal shoulder 326 is not pressed by thepressing surfaces 1000 during crimping. The delivery apparatus mayfurther be held in a defined axial position relative to the prostheticvalve 922 positioned upon the support body 1010 (FIG. 51 ).

An exemplary method of operation of the systems disclosed herein mayinclude the following steps. Steps may be modified, excluded, orsubstituted across embodiments as desired.

Initially, the ring body 1038 can be positioned upon the support body1010 in a configuration shown in FIG. 48 for example. The ring body 1038may be rotationally oriented upon the support body 1010 in a definedposition, for example, via the coupling of the coupler 1070 shown inFIG. 47 with the recess 1022 shown in FIG. 48 . As such, the prostheticvalve 922 may be positioned upon the support surface 1015 with thecommissures 944 a-c of the prosthetic valve 922 circumferentiallyaligned with the indicators 1050 a-c (as shown in FIG. 50 ). Theprosthetic valve 922 may be abutted against the ring body 1038.

With the prosthetic valve 922 positioned upon the support surface 1015,in the desired rotational alignment, the ring body 1038 may then beremoved from the support body 1010, prior to crimping the prostheticvalve 922 to the delivery apparatus. For example, the levers 1066, 1068may be pressed to rotate the arms 1052, 1054 about the pivot 1060 andopen the ring body 1038.

With the ring body 1038 removed, the support body 1010 may be insertedinto the crimping device 1084 with the prosthetic valve 922 positionedaround the support portion 1012. FIG. 51 , for example, illustrates theprosthetic valve 922 positioned on and around the support portion 1012and the support body 1010 inserted into the channel of the crimpingdevice 1084.

The distal opening 1006 of the crimping device 1084 may be configuredfor the support body 1010 to be inserted into the channel 1090. Thechannel 1090 of the crimping device 1084 may be configured to receivethe prosthetic valve 922, the support body 1010, and the distal endportion 309 of the delivery apparatus.

Upon insertion of the support body 1010 into the channel 1090 of thecrimping device 1084, the alignment member 1024 can be aligned (e.g.,received within) with the cut-out portion 1008 of the crimping device1084. As such, the rotational orientation of the support body 1010within the channel 1090 of the crimping device 1084, and accordingly therotational orientation of the prosthetic valve 922 within the channel1090 of the crimping device 1084, may be set in the desired position.

With the support body 1010 and the prosthetic valve 922 inserted intothe channel 1090 of the crimping device 1084, the positioning device1072 (or an alternate positioning device, as described further below)can be coupled to the distal end portion 309 of the delivery apparatusand then inserted into the proximal opening 1094 of the crimping device1084 (FIG. 51 ). The flanges 1051 of the positioning device 1072 maymate with the corresponding mating structures 1096.

FIG. 51 illustrates a cross sectional view of the pressing surfaces 1000in position around the channel 1090 of the crimping device 1084, and thesupport body 1010 inserted into the channel 1090 with the prostheticvalve 922 positioned around the support portion 1012.

As shown in FIG. 51 , the support portion 1012 of the support body 1010extends axially within the channel 1090, toward the proximal opening1094 of the crimping device 1084. The support surface 1015 may besurrounded by the pressing surfaces 1000. The coupling portion 1013 ofthe support body 1010 can be arranged outside of and distal of thepressing surfaces 1000, and may be retained within the distal opening1006 of the crimping device 1084. The alignment member 1024 may extendproximally into the cut-out portion 1008 of the crimping device 1084.

In FIG. 51 , the valve mounting portion 324 of the delivery apparatus ispositioned within the channel 1090 of the crimping device 1084. Theprosthetic valve 922 is positioned within the channel 1090 and aroundthe valve mounting portion 324 of the delivery apparatus. The supportbody 1010 is positioned within the channel 1090 and between theprosthetic valve 922 and the delivery apparatus. The support body 1010supports the leaflets of the prosthetic valve 922 in an open position.The distal end portion 309 of the delivery apparatus extends distallywithin the interior channel 1090 of the crimping device 1084 anddistally within the central channel 1030 of the support body 1010.

When inserted into the crimping device 1084, the positioning device 1072may be coupled to the distal end portion 309 of the delivery apparatus,proximal to the valve mounting portion 324, and may be engaged with themating structures 1096 of the proximal face 1092.

The positioning device 1072 may be coupled to the distal end portion 309of the delivery apparatus at a location such that the valve mountingportion 324 is positioned at a desired location within the channel 1090and relative to the prosthetic valve 922. For example, as shown in FIG.51 , the prosthetic valve 922 may surround the valve mounting portion324.

As described above, the rotational alignment of the prosthetic valve 922relative to the distal end portion 309 of the delivery apparatus may bein a desired, predetermined orientation and/or position due to the prioruse of the ring body 1038.

With the distal end portion 309 of the delivery apparatus, support body1010, and prosthetic valve 922 in a desired position within the channel1090, the actuator of the crimping device 1084 may be actuated tocompress the prosthetic valve 922. For example, the handle 1088 may berotated to rotate the rotatable body 1098 and move the pressing surfaces1000 radially inward against the prosthetic valve 922 (FIGS. 43 and 44).

FIG. 52 , for example, illustrates the pressing surfaces 1000 havingbeen moved radially inward to apply a compressive force to theprosthetic valve 922. The prosthetic valve 922 is crimped to thedelivery apparatus, around the valve mounting portion 324, utilizing thepressing surfaces 1000 of the crimping device 1084. As shown in FIG. 52, in its radially compressed state, the prosthetic valve 922 hasincreased in length, in the axial direction.

Crimping the prosthetic valve 922 to the delivery apparatus may includeapplying a force to the support surface 1015 of the support body 1010with the pressing surfaces 1000, thereby causing the support body 1010to slide axially within the channel 1090, away from the prosthetic valve922 (FIG. 52 ).

For example, as described above, the tapered shape of the supportportion 1012 and the support surface 1015 can cause the support body1010 to slide distally away from the channel 1090 and away from thepressing surfaces 1000, as the pressing surfaces 1000 move radiallyinward. The support body 1010 is configured to releasably couple to thecrimping device 1084 and slide in a direction axially away from thechannel 1090 upon the crimping device 1084 crimping the prosthetic valve922. In some embodiments, the support body 1010 may eject out from thedistal opening 1006, as shown in FIG. 52 . The elongate shape of thealignment member 1024 may allow the alignment member 1024 to slide outof the cut-out portion 1008.

In embodiments, the support body 1010 may not eject, but may remaincoupled to the crimping device 1084 during crimping. The support body1010, for example, may slide distally while a tether or another form ofcoupler keeps the support body 1010 coupled to the crimping device 1084such that the support body 1010 does not fall.

Following the prosthetic valve 922 being crimped to the deliveryapparatus, the positioning device 1072 may be disengaged from the matingstructures 1096 and moved outward from the proximal opening 1094,thereby moving the delivery apparatus outward and away from the crimpingdevice 1084. The positioning device 1072 may then be removed from thedistal end portion 309 of the delivery apparatus, with the prostheticvalve 922 crimped to the delivery apparatus.

In this way, the use of a mounting assembly including the support body1010 may allow the leaflets of the prosthetic valve 922 to remain in anopen position during crimping. Such a feature may reduce the possibilityof degradation to the prosthetic valve 922 occurring during crimping.Further, the tapered shape of the support surface 1015 may allow thesupport body 1010 to be slid outward from the crimping device via theradially inward movement of the pressing surfaces 1000, such that thesupport body 1010 automatically is moved outward and away from thecrimped prosthetic valve 922. The support body 1010 may automaticallyslide axially outward such that the support surface 1015 is notpositioned between the prosthetic valve 922 and the pressing surfaces1000 following crimping. In some embodiments, the system may beconfigured such that a separate mechanism slides the support body 1010distally, such that a tapered shape may not be utilized for the supportsurface 1015. For example, arms or gears or another form of coupler mayengage the support body 1010 to move the support body 1010 away from theprosthetic valve 922.

In some embodiments, the mounting assembly can include a differentlyconfigured positioning device that is configured to mate with one ormore mating structures (e.g., mating structures 1096 of crimping device1084) arranged on one side of a crimping device. FIG. 53 shows anotherembodiment of a positioning device 1100 that can be used in a mountingassembly and coupled to a crimping device and FIGS. 54 and 55 show sideand perspective views, respectively, of the positioning device 1100coupled to the distal end portion 309 of the delivery apparatus 300,proximal to the valve mounting portion 324.

As shown in FIG. 53 , the positioning device 1100 can include a body1102 including a first portion 1104 and a second portion 1106 pivotablycoupled to one another via a hinge 1108. The body 1102 can include acentral channel 1110 (FIG. 53 ) that is configured to receive theintermediate shaft 306 (or another shaft portion, such as the outershaft 304) of the delivery apparatus 300 (FIGS. 54 and 55 ).

The second portion 1106 of the body 1102 can include a flange portion1112 extending radially outward therefrom and arranged at a distal endof the positioning device 1100. The flange portion 1112 can include oneor more mating elements that are configured to mate with correspondinglyshaped mating features in a side surface (e.g., proximal face) of acrimping device. In some embodiments, as shown in FIG. 53 , the matingelements are configured as circumferentially extending extensionportions 1114. In some embodiments, the extension portions 1114 can bespaced apart from one another around a circumference of the flangeportion 1112.

In some embodiments, the flange portion 1112 can include one or moreindicating elements 1116 that can indicate an orientation of insertionof the extension portions 1114 into the crimping device.

As shown in FIGS. 54 and 55 , the positioning device 1100 is clampedaround the intermediate shaft 306 at a location proximal to and adjacentto a proximal end portion of the balloon 318.

Alternate embodiments of mounting assemblies that are configured tocrimp a prosthetic valve onto a delivery apparatus at a predeterminedposition and/or orientation relative to the delivery apparatus aredescribed in International Patent Application No. PCT/US19/28831, whichis incorporated by reference herein.

FIG. 56 is a flow chart of an exemplary method 1200 for crimping aprosthetic valve into a radially compressed state to a distal endportion of a delivery apparatus, in a predetermined position and in apredetermined orientation relative to the delivery apparatus. In someembodiments, method 1200 may utilize one or more components of themounting assemblies described herein with reference to FIGS. 43-55 .

Method 1200 begins at 1202 by placing (e.g., positioning) a prostheticvalve (e.g., prosthetic valve 10 of FIG. 1 , prosthetic valve 50 ofFIGS. 2A-2B, or prosthetic valve 922 of FIG. 41 ) onto an implant holderdevice such that one or more commissures of the prosthetic valve alignwith one or more corresponding indicators or alignment markers on analignment ring (or ring body) coupled to the implant holder device. Theimplant holder device can be configured to receive an at least partiallyradially expanded prosthetic valve and hold the prosthetic valve in adesired circumferential orientation. In some embodiments, the implantholder device can be the support body 1010 of FIGS. 45 and 48 and thealignment ring can be the ring body 1038 of FIGS. 46-48 and 50 . Forexample, in some embodiments, the method at 1200 can includerotationally aligning the prosthetic valve on a support portion of thesupport body such that one or more commissures of the prosthetic valvematch up and align with corresponding indicators on the ring body (e.g.,as shown in FIG. 50 ). In alternate embodiments, the alignment ring canbe one of the alignment rings shown in FIGS. 65-68 .

After aligning the commissures of the prosthetic valve on the implantholder device, method 1200 proceeds to 1204, which includes removing thealignment ring from the implant holder device, while thecircumferentially aligned prosthetic valve remains attached to theimplant holder device.

At 1206, the method includes attaching a positioning device to thedelivery apparatus. In some embodiments, attaching the positioningdevice can include coupling a portion of the positioning device around ashaft of the delivery apparatus, proximal to a valve mounting portion ofthe delivery apparatus and a proximal portion of an inflatable balloonof the delivery apparatus. In some embodiments, the positioning devicecan be coupled to and around the intermediate (e.g., balloon shaft) ofthe delivery apparatus (e.g., intermediate shaft 306, as shown in FIG.54 ). The positioning device can be one of the positioning devicesdescribed herein (e.g., positioning device 1072 of FIG. 49 orpositioning device 1100 of FIGS. 53-55 ) or another positioning deviceconfigured to couple to the delivery apparatus and a crimping device andhold the delivery apparatus in a desired circumferential orientationrelative to the crimping device. For example, the method at 1206 caninclude coupling the positioning device to the delivery apparatus suchthat a radiopaque marker on the delivery apparatus is held in a desiredcircumferential orientation within the crimping device, upon couplingthe positioning device with the crimping device.

Method 1200 proceeds to 1208 and includes placing (e.g., arranging orcoupling) the distal end portion of the delivery apparatus and thepositioning device into a first (e.g., proximal) side of a crimpingdevice (e.g., crimping device 1084 of FIGS. 43 and 44 or anothercrimping device). For example, a flange portion of the positioningdevice including one or more mating elements can be coupled to the firstside of the crimping device such that the one or more mating elementsmate with one or more corresponding mating elements in the first side ofthe crimping device. As a result, the distal end portion of the deliveryapparatus, coupled with the positioning device, can be arranged withinthe crimping device, with the valve mounting portion arranged within aportion of the crimping device configured to press against and crimp theprosthetic valve. In this way, the positioning device and the valvemounting portion of the delivery apparatus can be received within thecrimping device in a predetermined circumferential orientation andposition.

At 1210, the method includes placing the implant holder device into asecond (e.g., distal) side of the crimping device. For example, themethod at 1210 can include inserting the implant holder device into thesecond side of the crimping device such that an alignment member of theimplant holder device inserts into and/or mates with a correspondingmating structure or element of the crimping device. In this way, theimplant holder device and the prosthetic valve arranged on the implantholder device can be received within the crimping device in apredetermined orientation. For example, when both the implant holderdevice coupled to the prosthetic valve and the positioning devicecoupled to the delivery apparatus are coupled with the crimping device,a selected commissure of the prosthetic valve can be offset, in acircumferential direction relative to a central longitudinal axis of thedelivery apparatus, from a radiopaque marker (e.g., such as one of themarkers shown in FIG. 28, 18A-18B, or 42) on the distal end portion ofthe delivery apparatus by a predetermined amount.

At 1212, the method includes crimping the prosthetic valve into aradially compressed state onto the valve mounting portion of thedelivery apparatus using the crimping device. In some embodiments,crimping the prosthetic valve at 1212 can include crimping theprosthetic valve into its radially compressed state around an inflatableballoon, at the valve mounting portion. Additionally, in someembodiments, crimping the prosthetic valve at 1212 can include crimpingthe prosthetic valve into the radially compressed state on the valvemounting portion of the delivery apparatus while maintaining thepredetermined amount of offset between the radiopaque marker and theselected commissure of the prosthetic valve (e.g., as shown in FIG. 42 ,as described above). As described further below, the predeterminedamount of offset can be determined (e.g., preselected) based on adesired or selected imaging view used to image the distal end portion ofthe delivery apparatus during an implantation procedure and rotationallyalign the prosthetic valve with the native anatomy (e.g., to achievecommissure alignment).

During crimping at 1212, in some embodiments, the implant holder devicecan automatically uncouple from the prosthetic valve and/or the crimpingdevice (e.g., as described above with reference to FIGS. 51 and 52 ).

At 1214, the method includes removing the distal end portion of thedelivery apparatus, with the prosthetic valve crimped thereon, from thecrimping device. The method at 1214 can further include removing (e.g.,uncoupling) the positioning device from the delivery apparatus. In thisway, the positioning device can be removably coupled to the deliveryapparatus and the implant holder device can be removably coupled to theprosthetic valve, as described above.

After removal from the crimping device, the delivery apparatus may thenbe prepared for insertion into a vessel of a patient and for navigationto the patient's heart.

FIG. 57 is a flow chart of an exemplary method 1300 for implanting aprosthetic valve at a native valve of a heart of a patient with one ormore selected commissures of the prosthetic valve in alignment (e.g., ina circumferential direction) with one or more corresponding commissuresof the native valve. In some embodiments, method 1300 can be carried outwith a delivery apparatus that is configured to deploy a radiallycompressed prosthetic valve mounted on a distal end portion of thedelivery apparatus via inflating a balloon of the delivery apparatus.

An exemplary delivery apparatus 300 is shown in FIGS. 9-11 . Thedelivery apparatus can include one or more of the components describedherein to aid in rotationally aligning the delivery apparatus at theimplantation site (e.g., native valve) to achieve the above-describedcommissure alignment. In alternate embodiments, method 1300 can becarried out with a delivery apparatus that is configured to deploy aradially compressed valve by axially moving a sheath or capsule coveringa radially compressed prosthetic valve relative to a shaft of thedelivery apparatus (and thus moving the capsule instead of inflating theballoon to deploy the prosthetic valve).

Method 1300 begins at 1302 and includes receiving a prosthetic heartvalve mounted on a distal end portion of a delivery apparatus, around aninflatable balloon of the delivery apparatus and in a radiallycompressed configuration, at a predetermined position and in apredetermined orientation relative to the delivery apparatus, such thata selected commissure of the prosthetic heart valve is offset, in acircumferential direction relative to a central longitudinal axis of thedelivery apparatus, from a radiopaque marker on the distal end portionof the delivery apparatus by a predetermined amount. In someembodiments, the predetermined amount is determined based on a selectedimaging view, as described further below, with reference to FIGS. 58-68.

In some embodiments, as described above with reference to FIGS. 30-34B,the marker can be reflection asymmetric along an axis that is parallelto the central longitudinal axis. In some embodiments, the marker can bepositioned on a polymeric body of the delivery apparatus, such as aproximal shoulder, distal shoulder, or nose cone. In some embodiments,the marker is arranged on and/or embedded in a flared portion of adistal shoulder of the delivery apparatus, the distal shoulder arrangeddistal to the valve mounting portion of the delivery apparatus (e.g., asshown in FIGS. 32A-32B and 42 ).

In some embodiments, the method at 1302 can include crimping theprosthetic heart valve onto the distal end portion of the deliveryapparatus using a mounting assembly, as described above with referenceto the method of FIG. 56 .

At 1304, the method includes advancing the distal end portion of thedelivery apparatus toward a native valve of a heart of a patient. Insome embodiments, the method at 1304 can additionally include, firstinserting the distal end portion of the delivery apparatus intovasculature of the patient with an inflation port of an adaptor of thedelivery apparatus facing toward a user (e.g., the user performing theimplantation procedure) in order to orient the radiopaque markerentering the patient such that it faces a table on which the patient ispositioned (e.g., due to the arrangement of the adaptor 312 androtatable knob 314 relative to the marker, as described above withreference to FIGS. 15-22 ).

After advancing the distal end portion of the delivery apparatus to alocation proximate to the native valve (e.g., within the patient'sheart), the method continues to 1306 and includes visualizing, underfluoroscopy and for a selected imaging view, a position of theradiopaque marker on the distal end portion of the delivery apparatusrelative to a guidewire extending through a shaft of the deliveryapparatus. For example, as described above with reference to FIGS. 29,31A-31B, and 34A-34B, using medical imaging, such as fluoroscopy, theradiopaque marker can be visualized, along with the guidewire andadditional components (e.g., the valve frame of the prosthetic valvemounted on the delivery apparatus). A position of the radiopaque markerrelative to the guidewire can be seen in the selected imaging view(e.g., the marker can appear radially offset from the guidewire when notdirectly in front of or behind the guidewire in the imaging view, asshown in the example of FIG. 29 ). Thus, since fluoroscopy does notprovide perspective to naturally differentiate what is in the front vs.the back of the selected imaging view, this perspective can be providedby visualizing a position of the asymmetric marker relative to theguidewire, as described further below.

As described further below with reference to FIGS. 61-64 , a user canselect from a plurality of possible imaging views for imaging the heartand the position of the distal end portion of the delivery apparatusrelative to the native valve. For each imaging view, a location of atarget commissure of the native valve that is to be aligned with aselected commissure of the prosthetic heart valve (after implantation),within the selected imaging view, may be known. An exemplaryfluoroscopic image 1400 of a native (e.g., aortic) valve 1402 viewedwith a more standard, three-cusp imaging view is shown in FIG. 58 . Asshown in FIG. 58 , the native aortic valve 1402 includes three leaflets:the non-coronary cusp 1404, the right coronary cusp 1406, and the leftcoronary cusp 1408. In the three-cusp view, the non-coronary cusp 1404and the left coronary cusp 1408 are arranged opposite one another in theview and are each overlapped by a portion of the right coronary cusp1406. As such, a commissure between the non-coronary cusp 1404 and theleft coronary cusp 1408 is in known to be located in the back of theimage 1400.

At 1308, the method includes, prior to crossing the native valve,rotating the shaft of the delivery apparatus, which rotates theprosthetic heart valve and the marker, until the marker is centeredalong the guidewire and is in a predetermined orientation in theselected imaging view. The method at 1308 can be performed while imagingthe heart and viewing the selected imaging view.

In some embodiments, the predetermined orientation in the selectedimaging view is a direct back of the imaging view (e.g., away from theviewer). In alternate embodiments, the predetermined orientation in theselected imaging view can be a direct front of the imaging view (e.g.,toward the viewer). Thus, in some embodiments, the radiopaque marker canbe configured as an asymmetric marker that has a first orientation whenit is in front of the guidewire (e.g., in the direct front of theimaging view) and a different, second orientation when it is behind theguidewire (e.g., in the direct back of the imaging view). In this way,the asymmetric marker can help a user differentiate between the markerbeing positioned in the front and the back of the selected imaging view(as compared to a symmetric marker which would appear the same to aviewer in an imaging view, whether the marker is behind or in front ofthe guidewire).

For example, in some embodiments, as shown in FIG. 59 , the asymmetricmarker 600 can be configured as a letter of the alphabet that appearsforward (e.g., forward-readable “C”, as shown in FIG. 31A) when themarker is centered along the guidewire 606 and is arranged in the directback of the imaging view (e.g., behind the guidewire, as shown in FIG.59 ) and appears backward (e.g., backwards “C”, as shown in FIG. 31B)when the marker is centered along the guidewire and is arranged in thedirect front of the imaging view. Thus, the method at 1308 can includerotating the shaft of the delivery apparatus, which rotates theprosthetic heart valve and the marker, until the marker appears centeredalong the guidewire and in its forward orientation, within the selectedimaging view, thereby positioning the marker in the direct back of theimaging view.

In alternate embodiments, the asymmetric marker can appear forward whenthe marker is centered along the guidewire and is arranged in the directfront of the imaging view (e.g., in front of the guidewire) and appearsbackward when the marker is centered along the guidewire and is arrangedin the direct back of the imaging view. Thus, in these embodiments, themethod at 1308 can include rotating the shaft of the delivery apparatus,which rotates the prosthetic heart valve and the marker, until themarker appears centered along the guidewire and in its backwardorientation, within the selected imaging view, thereby positioning themarker in the direct back of the imaging view.

In still other embodiments, the method at 1308 can include rotating theshaft of the delivery apparatus, which rotates the prosthetic heartvalve and the marker, until the marker appears centered along theguidewire and is in a predetermined orientation (backward or forward)within the selected imaging view, thereby positioning the marker in thedirect front of the imaging view. In this way, the predetermined offsetbetween the selected commissure of the prosthetic heart valve and themarker on the delivery apparatus can be determined based on both theselected imaging view and the target orientation of the marker in theselected imaging view (direct front or direct back).

By rotating the distal end portion of the delivery apparatus prior tocrossing the native valve, blood flow through the native valve (whichmay be stenosed) may not be occluded by the delivery apparatus.Additionally, in some embodiments, if the crimped prosthetic valve wereto be rotated within (e.g., across) the native valve (which may havecalcified leaflets), emboli could be generated by knocking off pieces ofcalcium from the leaflets, which could lead to stroke or other medicalcomplications. Thus, by rotating the distal end portion of the deliveryapparatus and the radially compressed prosthetic valve outside of thenative valve (e.g., in the ascending aorta), emboli and othercomplications can be reduced or avoided. Further, a user can take moretime for the rotating since the delivery apparatus is not in a positionthat can occlude blood flow through the native valve.

After achieving the desired rotational positioning of the radiopaquemarker relative to the guidewire at 1308, the method continues to 1310,which includes advancing the distal end portion of the deliveryapparatus including the radially compressed prosthetic heart valveacross and into the native valve and inflating the balloon to radiallyexpand and implant the prosthetic heart valve in the native valve suchthat the selected commissure of the prosthetic heart valve is alignedwith the target commissure of the native valve.

In some embodiments, during the inflating, as the prosthetic heart valveradially expands, the prosthetic heart valve rotates by an amount equalto the predetermined amount of offset between the marker and theselected commissure when the prosthetic heart valve is radiallycompressed around the balloon. For example, as shown in the exemplaryschematic of FIG. 60 , when the target commissure 1450 of the nativevalve 1452 is known to be in the direct back of the selected imagingview used for rotational positioning at the implantation site, and themarker 600 is aligned at the direct back of the selected imaging view,the prosthetic valve 922 can rotate by an amount (as shown by arrow 1454in FIG. 60 ) that is equal to the predetermined amount of offset betweenthe marker and the selected commissure 930 of the prosthetic valve 922when the prosthetic heart valve is radially compressed around theballoon, thereby implanting the prosthetic valve 922 with the selectedcommissure 930 circumferentially aligned with the target commissure 1450of the native valve 1452.

In alternate embodiments, during the inflating, as the prosthetic heartvalve radially expands, the prosthetic heart valve rotates by an amountthat is more or less than the amount of offset between the marker andthe selected commissure when the prosthetic heart valve is radiallycompressed around the balloon. However, this amount of offset can bepredetermined based on the selected imaging view and a preexistingknowledge of a location of the target commissure of the native valvewithin the selected imaging view. In this way, during method 1300, themarker on the delivery apparatus can still be aligned with the guidewire(e.g., in the direct back of the selected imaging view), but thepredetermined amount of offset between the marker and the selectedcommissure of the radially compressed prosthetic valve can be adjustedfor different imaging view such that, upon inflation of the balloon, theprosthetic valve rotates and is implanted with commissures in alignmentwith commissure of the native valve.

Examples of this rotational alignment and adjustment of thecircumferential offset between the marker on the delivery apparatus andthe selected commissure of the radially compressed prosthetic heartvalve, for different imaging views, are described below with referenceto FIGS. 61-68 .

A schematic of a first embodiment of a more standard, three-cusp imagingview 1500 of a native valve 1510 that can be used for visualizing thedelivery apparatus in a patient's heart during an implantation procedureand rotationally aligning the prosthetic valve, as described above, isshown in FIG. 61 . In the three-cusp imaging view 1500, the non-coronarycusp 1502 of the native valve (e.g., aortic valve) 1510 and the leftcoronary cusp 1504 are arranged opposite one another in the view andeach are overlapped by a different portion of the right coronary cusp1506, with all three cusps aligned along a transverse axis 1508. Thus,as shown in the cross-sectional view of the native valve 1510 in FIG. 62, for the three-cusp imaging view 1500, a selected commissure 1512 ofthe native valve 1510, which is arranged between the non-coronary cusp1502 and the left coronary cusp 1504 is arranged in the direct back 1514of the three-cusp imaging view 1500. FIG. 62 also shows the direct front1516 of the imaging view, in which the right coronary cusp 1506 islocated.

In contrast, FIG. 63 shows a schematic of a second embodiment of adifferent, right/left cusp overlap view 1550 of the native valve 1510that can be used for visualizing the delivery apparatus in the patient'sheart during an implantation procedure and rotationally aligning theprosthetic valve, as described above. In the right/left cusp overlapview 1550, the left coronary cusp 1504 and the right coronary cusp 1506overlap one another and the non-coronary cusp 1502 is offset from theleft coronary cusp 1504 and the right coronary cusp 1506. As shown inthe cross-sectional view of the native valve 1510 in FIG. 64 , for theright/left cusp overlap view 1550, the selected commissure 1512 iscircumferentially offset from the direct back 1514 of the imaging view.

It should be noted that, in alternate embodiments, a differentcommissure of the native valve (other than the commissure arrangedbetween the arranged between the non-coronary cusp and the left coronarycusp) can the selected commissure on which the predetermined offsetbetween the marker and the selected commissure of the prosthetic valveis at least partially based.

Thus, for the two different imaging views shown in FIGS. 61 and 63 , thecircumferential offset between the radiopaque marker on the deliveryapparatus and the selected commissure of the radially compressedprosthetic valve can be different predetermined offset values. In someembodiments, the implantation procedure can proceed in a same way forthe different imaging views (e.g., the method at 1304, 1306, 1308, and1310 can proceed as described above, using the different, selectedimaging views), including rotationally aligning the radiopaque marker onthe delivery apparatus with the guidewire such that the marker ispositioned in the direct back of the imaging view (e.g., as shown inFIGS. 59 and 60 ). However, the mounting of the prosthetic valve to thedelivery apparatus can be adjusted such that a different amount ofcircumferential offset between the marker and the selected commissure ofthe prosthetic valve is used for the different procedures using thedifferent imaging views, where the determined amount of circumferentialoffset for the selected imaging view results in the prosthetic valvebeing implanted in the native valve with commissures in alignment withcommissures of the native valve.

It should be noted that the two imaging views shown in FIGS. 61 and 63are examples of two different imaging views that could be used during avalve implantation procedure for rotationally aligning the prostheticvalve at the native valve. However, additional, different imaging viewsthat position a target commissure of the native valve in a differentlocation relative to the direct back (or front) of the selected imagingview are possible and can also be used with the systems and methodsdescribed herein. In this way, a user can select from a plurality ofpossible imaging views and the circumferential location of the selected(or target) commissure (e.g. commissure 1512 shown in FIGS. 62 and 64 )relative to the back (or front) of the selected imaging view can beknown (e.g., predetermined).

In some embodiments, different alignment rings (e.g., ring bodies,similar to ring body 1038 shown in FIGS. 46-48 ) for a mounting assemblyor different indicators on an alignment ring denoting an alignmentlocation for one or more commissures of the prosthetic valve arranged onan implant holder device (e.g., such as support body 1010 of FIGS. 45and 48 ) can be used for different selected imaging views for the valveimplantation procedure.

FIGS. 65-68 show exemplary embodiments of different alignment rings thatcan be used in a mounting assembly and are configured to rotationallyalign the prosthetic valve on an implant holder device, therebyresulting in the prosthetic valve being crimped onto a valve mountingportion of a delivery apparatus in a predetermined circumferentialorientation relative to a radiopaque marker on the distal end portion ofthe delivery apparatus. For example, the alignment rings can beconfigured such that the prosthetic valve is radially compressed ontothe delivery apparatus with a selected commissure circumferentiallyoffset from the radiopaque marker on the distal end portion of thedelivery apparatus by a predetermined amount that is determined (e.g.,selected) based on the selected imaging view for use during animplantation procedure. In some embodiments, as shown in FIGS. 65 and 66, different alignment rings can be similar in overall shape and functionbut have a different arrangement of indicators or markers that areunique for a selected imaging view intended to be used. For example, thedifferent alignment rings having a unique arrangement of indicators ormarkers can be configured to align the prosthetic valve on an implantholder device in such a way as to offset a selected commissure of theprosthetic valve relative to the radiopaque marker on the deliveryapparatus by the appropriate amount that aligns the commissures of theprosthetic valve with the native valve when the prosthetic valve isdeployed from the delivery apparatus with the radiopaque marker alignedwith the guidewire, as described above.

FIG. 65 shows one embodiment of an alignment ring 1600 which can beconfigured to rotationally align a prosthetic valve relative to adelivery apparatus for an implantation procedure using a first imagingview, such as the three-cusp imaging view (e.g., the three-cusp imagingview 1500 of FIG. 61 ), to rotationally align and implant the prostheticvalve with the delivery apparatus at the native valve. The alignmentring 1600 can be configured to enable mounting of the prosthetic valveonto a delivery apparatus with a selected commissure of the prostheticvalve circumferentially offset from a radiopaque marker on the deliveryapparatus by a first predetermined amount, the first predeterminedamount resulting in the prosthetic valve being implanted withcommissures in alignment with commissures of the native valve followingdeployment of the prosthetic valve with the delivery apparatus havingthe radiopaque marker aligned with the guidewire in its predeterminedorientation (e.g., which indicates the marker is arranged in the directback of the imaging view).

The alignment ring 1600 can be configured (e.g., structured) similarlyto or the same as the ring body 1038 of FIGS. 46 and 47 . For example,the alignment ring 1600 can include one or more indicators (e.g.,alignment indicators or markers) 1610 a-c arranged on one or moresurfaces of a body 1602 of the alignment ring 1600. As described abovewith reference to FIGS. 46 and 47 , the indicators 1610 a-c can bedepressions (e.g., grooves) or etchings into the one or more surfaces,raised features extending radially outward from the one or moresurfaces, and/or markings (e.g., lines printed, painted, or stampedonto) on the one or more surfaces.

As shown in FIG. 65 , the alignment ring 1600 includes three indicators1610 a-c spaced apart from one another around a circumference of thealignment ring 1600. However, in alternate embodiments, the alignmentring 1600 can include less than three indicators 1610 a-c, such as oneor two. The indicators 1610 a-c can be configured to indicate a desiredorientation for the commissures of the prosthetic valve when mountingthe prosthetic valve around an implant holder device (e.g., such assupport body 1010 shown in FIGS. 45 and 48 ) when the alignment ring iscoupled to the implant holder device (e.g., as shown in FIG. 48 ). Asshown in FIG. 65 , a first indicator 1610 a can be spaced apart from afirst lever (e.g., radial extension) 1604 by a first arc length 1606.

In some embodiments, the alignment ring 1600 can include an additionalmarking or indicator that indicates its intended use for alignment of aprosthetic valve to be implanted in an implantation procedure using thethree-cusp imaging view. For example, as shown in FIG. 65 , thealignment ring includes a first label 1608 (“View A”) that indicates theselected imaging view for the implantation procedure. In someembodiments, the selected imaging view (View A) can be the three-cuspimaging view described above. In alternate embodiments, the first label1608 can be a color coding, a symbol, a numeric code, or the like.

FIG. 66 shows another embodiment of an alignment ring 1700 which can beconfigured to rotationally align a prosthetic valve relative to adelivery apparatus for an implantation procedure using a second imagingview, such as the right/left cusp overlap imaging view (e.g., right/leftcusp overlap view 1550 of FIG. 63 ), to rotationally align and implantthe prosthetic valve with the delivery apparatus at the native valve.The alignment ring 1700 can be configured to enable mounting of theprosthetic valve onto a delivery apparatus with a selected commissure ofthe prosthetic valve circumferentially offset from a radiopaque markeron the delivery apparatus by a second predetermined amount, the secondpredetermined amount resulting in the prosthetic valve being implantedwith commissures in alignment with commissures of the native valvefollowing deployment of the prosthetic valve with the delivery apparatushaving the radiopaque marker aligned with the guidewire in itspredetermined orientation (e.g., which indicates the marker is arrangedin the direct back of the imaging view). The second predetermined amountcan be different than the first predetermined amount described abovewith reference to the alignment ring 1600.

The alignment ring 1700 can be configured (e.g., structured) similarlyto or the same as the ring body 1038 of FIGS. 46 and 47 . For example,similarly to the alignment ring 1600, the alignment ring 1700 caninclude one or more indicators 1710 a-c arranged on one or more surfacesof a body 1702 of the alignment ring 1700.

As shown in FIG. 66 , the alignment ring 1700 includes three indicators1710 a-c spaced apart from one another around a circumference of thealignment ring 1700. However, in alternate embodiments, the alignmentring 1700 can include less than three indicators 1710 a-c, such as oneor two. The indicators 1710 a-c can be configured to indicate a desiredorientation for the commissures of the prosthetic valve when mountingthe prosthetic valve around an implant holder device (e.g., such assupport body 1010 shown in FIGS. 45 and 48 ) when the alignment ring iscoupled to the implant holder device (e.g., as shown in FIG. 48 ). Asshown in FIG. 66 , a first indicator 1710 a can be spaced apart from afirst lever (e.g., radial extension) 1704 by a second arc length 1706.

In some embodiments, the alignment ring 1700 can include an additionalmarking or indicator that indicates its intended use for alignment of aprosthetic valve to be implanted in an implantation procedure using thethree-cusp imaging view. For example, as shown in FIG. 66 , thealignment ring includes a first label 1708 (“View B) that indicates theselected imaging view for the implantation procedure. In someembodiments, the selected imaging view (View B) can be the right/leftcusp overlap view, as described above. In alternate embodiments, thefirst label 1708 can be a color coding, a symbol, a numeric code, or thelike.

FIGS. 65 and 66 show two possible embodiments of individual alignmentrings that are configured for use with differently selected imagingviews for a valve implantation procedure, as described herein. However,additional alignment rings configured similarly to those shown in FIGS.65 and 66 but with a different orientation of indicators (commissuremarkers) for differently selected imaging views are also possible. Inthis way, in some embodiments, a user can select from a plurality ofdifferent alignment rings that are unique to a selected imaging view,for an implantation procedure.

FIG. 67 shows another embodiment of an alignment ring 1800. Thealignment ring 1800 can be similar to the other alignment rings (or ringbodies) described herein but includes multiple sets of indicators (e.g.,alignment markers) for use in two or more implantation proceduresutilizing differently selected imaging views. For example, the alignmentring 1800 can be configured for intended use with two differentfluoroscopic imaging views. In the example of FIG. 67 , the alignmentring 1800 includes a first set of indicators 1802 and a second set ofindicators 1804 which are circumferentially offset from one another. Inone embodiment, the first set of indicators 1802 can be used for animplantation procedure utilizing the three-cusp imaging view and thesecond set of indicators 1804 can be used for a different implantationprocedure utilizing the right/left cusp overlap view.

In some embodiments, the first set of indicators 1802 can have adifferent color than the second set of indicators 1804. In this way, thedifferent colored indicators can correspond to the different imagingviews.

In other embodiments, the first set of indicators 1802 can have adifferent marking (e.g., lines vs. dots) than the second set ofindicators 1804. In still other embodiments, the first set of indicators1802 can be arranged on a first side (or surface) of the alignment ring1800 while the second set of indicators 1804 can be arranged on anopposite, second side (or surface) of the alignment ring 1800.

FIG. 68 shows another embodiment of an alignment ring 1900. Thealignment ring 1900 can be similar to the other alignment rings (or ringbodies) described herein but includes one or more sets of indicators1902, each set of indicators including a plurality of graduatedindicators (or markings). For example, each set of indicators 1902 caninclude a first (e.g., standard or base) indicator 1904, a secondindicator 1906 that is circumferentially offset from the first indicator1904 by a first amount (e.g., 10°), a third indicator 1908 that iscircumferentially offset from the first indicator 1904 by a secondamount (e.g., 20°), and a fourth indicator 1910 that iscircumferentially offset from the first indicator 1904 by a third amount(e.g., 30°). In alternate embodiments, the sets of indicators 1902 caninclude more or less graduated markings than those shown in FIG. 68 .

A graduated alignment ring having a plurality of graduated markings forone or more commissure locations, such as alignment ring 1900, can beuseful for patients with atypical anatomy or for user-customized imagingviews. For example, a user (e.g., physician) can identify from apre-procedure CT (or other imaging modality) that the patient has anative valve with commissures and/or coronary arteries in unusual (e.g.,non-standard) locations. Thus, a more customizable alignment ring, suchas the graduated alignment ring 1900, can allow the physician to offsetthe prosthetic valve commissures from the more standard location. Forexample, the offset of a native valve commissure from the expectedlocation could be measured in the pre-procedure CT and then physiciancould then ask a user to offset the prosthetic valve commissures by 20°from standard on the alignment ring and implant holder device (e.g.,using the third indicators 1908 shown in FIG. 68 ).

In this way, methods, assemblies, and/or apparatuses are provided forimplanting a prosthetic heart valve at a native valve with commissuresof the prosthetic heart valve being circumferentially aligned withcommissures of the native valve. As a result, access to the coronaryarteries can be increased.

In some embodiments of the delivery apparatuses and/or methods describedherein, a distal end portion of the delivery apparatus can include avalve mounting portion that is configured to receive a radiallycompressed prosthetic valve thereon and a polymeric body arrangedproximate to the valve mounting portion. In some embodiments, thepolymeric body can include a radiopaque marker that is configured toindicate a location of a commissure of the prosthetic valve afterradially expanding the prosthetic valve via inflating a balloon of thedelivery apparatus. In some embodiments, the polymeric body can includea radiopaque marker that is configured to be aligned with a guidewireextending through a center of the delivery apparatus in a predeterminedorientation such that the prosthetic valve is implanted with commissuresin alignment with commissures of a native valve.

In some embodiments, the methods, assemblies, and/or apparatuses canadditionally or alternatively include a method of arranging and radiallycompressing a prosthetic valve onto a valve mounting portion of adelivery apparatus such that a selected commissure of the prostheticvalve is in a predetermined position and orientation relative to theradiopaque marker of the delivery apparatus.

In some embodiments, the methods, assemblies, and/or apparatuses canadditionally or alternatively include a method of forming and/or foldingthe balloon of the delivery apparatus that results in a consistentamount of rotation of the prosthetic valve during deployment of theprosthetic valve into is radially expanded state. As a result, afterinflation of the balloon and radially expanding the prosthetic valve,the selected commissure of the prosthetic valve may be aligned, in acircumferential direction, with the radiopaque marker of the deliveryapparatus and/or a target commissure of the native valve.

In some embodiments, the methods, assemblies, and/or apparatuses canadditionally or alternatively include a delivery apparatus that isconfigured to rotate the balloon of the delivery apparatus with thecrimped (e.g., radially compressed) prosthetic valve without adverselyaffecting a flexing capability of the distal end portion of the deliveryapparatus and/or inflation of the balloon.

In some embodiments, the methods, assemblies, and/or apparatuses canadditionally or alternatively include the delivery apparatus with theradiopaque marker, where the radiopaque marker is visible underfluoroscopy and has an asymmetric shape that allows a user to determinewhether the maker is positioned in a front or a back of the fluoroscopicview (e.g., as viewed by the user).

In some embodiments, the methods, assemblies, and/or apparatuses canadditionally or alternatively include a method for rotating the distalend portion of the delivery apparatus, including the radiopaque markerand the radially compressed prosthetic valve, during an implantationprocedure, to rotationally align the marker with a target commissure ofthe native valve where the prosthetic valve is intended to be implanted,a guidewire extending through the delivery apparatus, and/orpredetermined location within a selected imaging view. In someembodiments, the method for rotating can occur during a selected portionof the implantation procedure that reduces a likelihood of clinicalcomplications occurring.

In some embodiments, the methods, assemblies, and/or apparatuses canadditionally or alternatively include a method for rotationally aligningthe radiopaque marker of the delivery apparatus with a selectedcommissure of the native valve, using a selected fluoroscopic viewobtained during the implantation procedure, and deploying the prostheticvalve within the native valve, with the delivery apparatus, such thatthe selected commissure of the prosthetic valve is circumferentiallyaligned with the selected commissure of the native valve.

Each of the above-described features of the methods, assemblies, and/orapparatuses can be combined with any one or more of the otherabove-described features of the methods, assemblies, and/or apparatuses.

In this way, a prosthetic valve can be more easily deployed at animplantation site such that commissures of the radially expandedprosthetic valve are aligned with commissures of the native valve,thereby avoiding placement of the commissures of the prosthetic valvefrom blocking and/or being positioned in front of the coronary arteries.As a result, blood flow into and access to the coronary arteries may beincreased.

In some embodiments, a balloon cover can be configured to enclose (e.g.,encase) a distal end portion of a delivery apparatus (e.g., a portion ofthe distal end portion 309 of the delivery apparatus 300 shown in FIGS.10 and 40-42 ) which includes an inflatable balloon mounted (and folded)thereon during shipping and/or storage prior to use and/or during ade-airing process.

For example, prior to crimping a prosthetic valve on the balloon of adelivery apparatus, the user typically performs a cyclic “de-airing”process that involves pushing inflation fluid into the balloon and thenwithdrawing the fluid out of the balloon, such as with a syringe fluidlyconnected to the handle of the delivery apparatus. The de-airing processcan be more effective when the balloon is allowed to at least partiallyinflate. However, inflation of the balloon outside of a balloon covercan result in un-folding of the balloon, which can inhibit or preventthe balloon from returning to its folded state (e.g., as shown in FIG.37 ) when the inflation fluid is removed from the balloon. A ballooncover can be configured to prevent complete unfolding of the balloonand/or assist the balloon in returning to its fully folded state afterthe inflation fluid is removed from the balloon.

Traditional balloon covers can comprise two shell portions or halvesthat are configured to be arranged and mated together around the distalend portion of the delivery apparatus, including the balloon (e.g., thedistal end portion 309 of delivery apparatus 300, with balloon 318mounted thereon, as shown in FIGS. 9-11 and 40 ). In some embodiments, aremovable sleeve can be slid over and around the assembled balloon coverin order to hold (and couple) the two shell portions of the ballooncover together. When a user is ready to mount or crimp a prostheticvalve onto the delivery apparatus, around the balloon (e.g., as shown inFIG. 41 ), a user can grab the delivery apparatus and pull to remove thesleeve from the delivery apparatus.

However, when the delivery apparatus includes a positioning devicecoupled to the distal end portion of the delivery apparatus (e.g.,positioning device 1100 coupled to the distal end portion 309 of thedelivery apparatus 300, as shown in FIGS. 54 and 55 or positioningdevice 1072 coupled to a distal end portion of a delivery apparatus, asshown in FIG. 49 ), a user may grab the positioning device duringremoval of the sleeve from the balloon cover. For example, a user maygrab the positioning device with one hand and then slide the sleeve offthe balloon cover and off a distal end of the delivery apparatus withthe other hand. This can result in movement of the positioning devicerelative to the delivery apparatus (and the radiopaque marker on thedistal end portion of the delivery apparatus, as described herein). As aresult, the prosthetic valve can be subsequently mounted onto theballoon in an improper circumferential orientation relative to themarker, which can result in misalignment of the commissures of theprosthetic valve with the commissures or the native valve, at theimplantation site (e.g., during an implantation procedure, as explainedabove with reference to FIG. 57 ).

To address such issues, a balloon cover for a balloon mounted on andaround a distal end portion of a delivery apparatus can comprise firstand second shell members, each having a narrower, first portionconfigured to receive (and enclose therein) the distal end portion ofthe delivery apparatus including the balloon and a wider, second portionconfigured to receive (and at least partially enclose therein) thepositioning device. In this way, the second portion can surround thepositioning device and prevent a user from directly contacting orgrabbing the positioning device, thereby avoiding any unwanted movement(e.g., rotation) of the positioning device relative to the deliveryapparatus during removal of the balloon cover from the deliveryapparatus.

FIGS. 69-76B and FIGS. 108-114 show embodiments of a balloon cover thatis configured to cover a portion of a distal end portion of a deliveryapparatus (e.g., distal end portion 309 of delivery apparatus 300, asshown in FIGS. 69, 72-76B, and 108-114 ) that includes an inflatableballoon (e.g., balloon 318) mounted thereon and a positioning devicecoupled to the distal end portion of the delivery apparatus, proximal toa valve mounting portion of the delivery apparatus (e.g., positioningdevice 1100, as shown in FIGS. 69, 72-76B, and 108-114 ).

FIGS. 69-75C show an exemplary embodiment of such a balloon cover (orballoon cover assembly) 2000 comprising a first cover portion 2001 thatis configured to cover at least a portion of the distal end portion ofthe delivery apparatus that includes the balloon and a second coverportion 2003 that is configured to cover the positioning device (coverportions 2001 and 2003 shown in FIGS. 72 and 73 ). The balloon cover2000 can comprise a first shell member 2002 and a second shell member2004 that are configured to matingly engage with each other and beremovably coupled to each other. For example, the first shell member2002 and the second shell member 2004 can comprise two halves of anouter shell 2006 of and/or forming the balloon cover 2000 (FIG. 69 ).

The outer shell 2006 and balloon cover 2000 are shown in a disassembledconfiguration in the exploded view of FIG. 69 and in an assembledconfiguration in the various views of FIGS. 72-75C. FIG. 70 shows thefirst shell member 2002, disassembled from a remainder of the ballooncover 2000. However, since in some embodiments the first shell member2002 and the second shell member 2004 can be configured the same (e.g.,identically formed), the first shell member 2002 shown in FIG. 70 mayalternatively be the second shell member 2004.

Additionally, FIGS. 71A-71C show details views of a mating interface2008 (FIG. 71C) between and related mating interface features or members(FIGS. 71A-71C) of the first shell member 2002 and the second shellmember 2004.

Each of the first shell member 2002 and the second shell member 2004includes a first portion (e.g., first shell portion) 2010 and a secondportion (e.g., second shell portion) 2012. In some embodiments, thefirst portion 2010 and the second portion 2012 of one of the first shellmember 2002 and the second shell member 2004 can be continuous with oneanother (e.g., formed as one piece). In some embodiments, the secondportion 2012 can have a second width 2018 that is larger than a firstwidth 2016 of the first portion 2010 (FIG. 70 ), the widths defined in aradial direction relative to a central longitudinal axis 2014 of theballoon cover 2000 (which can be coaxial with a central longitudinalaxis of the delivery apparatus when assembled and coupled around thedelivery apparatus). In some embodiments, the first width 2016 and thesecond width 2018 can be diameters.

When the first shell member 2002 and the second shell member 2004 areassembled together (e.g., in mating engagement), the first portions 2010of the first shell member 2002 and the second shell member 2004 can formthe first cover portion 2001 and define an elongate cavity 2020 (which,in some embodiments can be referred to as a lumen). The cavity 2020 canbe configured to receive a distal end portion of a delivery apparatusand at least a portion of a balloon (e.g., a majority portion in someembodiments) mounted on the distal end portion of the delivery apparatus(e.g., balloon 318 of the distal end portion 309, as shown in FIGS. 69and 72-75C).

For example, the first portion 2010 of the first shell member 2002 (andsimilarly, the second shell member 2004) comprises an outer surface 2022(FIGS. 69 and 70 ) and an inner surface 2024 (FIG. 70 ). The innersurface 2024 can be a mating surface that is configured to mate with ormatingly engage with (e.g., have face-to-face contact with) a respectiveinner surface of the first portion 2010 of the other (e.g., second)shell member forming the balloon cover 2000. In some embodiments, theinner surface 2024 can be a planar surface.

The first portion 2010 can further include a depression 2026 which isdepressed into the inner surface 2024 (toward the outer surface 2022).Together, the depressions 2026 of the first shell member 2002 and thesecond shell member 2004 can form the cavity 2020. Thus, each depression2026 of each of the first shell member 2002 and the second shell member2004 can define a half cavity portion 2021 of the cavity 2020 (FIG. 70).

Each depression 2026 can be shaped to receive a portion of the distalend portion 309 of the delivery apparatus. For example, each depression2026 can include a distal section 2028, a proximal section 2030, and anintermediate section 2032, the intermediate section 2032 disposedbetween the distal section 2028 and the proximal section 2030 (FIG. 70).

In some embodiments, the distal section 2028 can be shaped (e.g.,configured) to receive the balloon (e.g., balloon 318) and the portionof the delivery apparatus which the balloon overlays. For example, inthe embodiment shown in FIGS. 69-75C, the distal section 2028 can beshaped to receive a portion of the nose cone 322 and the distal endportion 332 of the balloon 318 which overlays the distal shoulder 326 ofthe delivery apparatus 300.

In some embodiments, the intermediate section 2032 can be shaped (e.g.,configured) to receive the intermediate portion 335 of the balloon andthe portion of the delivery apparatus 300 which the intermediate portion335 overlays (e.g., the valve mounting portion 324).

In some embodiments, the proximal section 2030 can be shaped (e.g.,configured) to receive at least a distal portion of the proximal endportion 333 of the balloon 318. In some embodiments, a more proximalportion of the proximal end portion 333 of the balloon 318 can extendinto the second portion 2012 of the first shell member 2002 or thesecond shell member 2004 (FIGS. 70 and 72 ). In other embodiments, theproximal section 2030 can be shaped to receive an entirety of theproximal end portion 333 of the balloon 318.

In this way, a shape or contour of the depression 2026 can vary along afirst length 2034 of the first portion 2010, the first length 2034extending in an axial direction relative to the central longitudinalaxis 2014 (FIG. 70 ). For example, as shown in FIG. 70 , theintermediate section 2032 is narrower than each of the distal section2028 and the proximal section 2030. In some embodiments, a width of theintermediate section 2032 is constant along a majority of a length ofthe intermediate section 2032.

In other embodiments, each depression 2026 can include the distalsection 2028 and a proximal section which may resemble the intermediatesection 2032 and extend from the distal section 2028 to the secondportion 2012. In such embodiments, the proximal section can beconfigured to receive the intermediate portion 335 of the balloon andthe portion of the delivery apparatus 300 which the intermediate portion335 overlays (e.g., the valve mounting portion 324). In someembodiments, the proximal section can be further configured to receivethe proximal end portion 333 of the balloon 318 which may not have awider diameter portion than the intermediate portion 335 when disposedwithin the balloon cover 2000. Such an exemplary embodiment is shown inFIGS. 108-114 , as described further below.

In some embodiments, the first length 2034 of the first portion 2010 canbe longer than a second length 2036 of the second portion 2012.

In other embodiments, the second length 2036 of the second portion 2012can be the same or longer than the first length 2034 of the firstportion 2010.

In some embodiments, the second length 2036 of the second portion 2012can be selected based on a length and/or size of the positioning device(e.g., positioning device 1100) to be contained within the secondportions 2012 of the first shell member 2002 and the second shell member2004 when they are coupled together in mating engagement. For example,in some embodiments, the second length 2036 can be the same or longerthan a length of the positioning device 1100. In some embodiments, thesecond length 2036 can be shorter than a length of the positioningdevice 1100, but long enough to cover enough of the positioning device(e.g., a majority portion or wider or larger diameter portions of thepositioning device) such that a user is blocked or deterred fromgrabbing onto the positioning device 1100.

When the first shell member 2002 and the second shell member 2004 areassembled to one another (e.g., coupled together in mating engagement),the second portions 2012 of the first shell member 2002 and the secondshell member 2004 can form the second cover portion 2003 and define acavity 2038 (FIGS. 69 and 72-75A). The cavity 2038 can be configured toreceive a positioning device (e.g., positioning device 1100, as shown inFIGS. 69 and 72-75C) mounted on the distal end portion 309 of thedelivery apparatus 300, proximal to a valve mounting portion 324 of thedistal end portion 309.

Inner surfaces of walls of the second portion 2012 can define one halfcavity portion 2040 of the cavity 2038 (FIG. 70 ). For example, as shownin FIG. 70 , the second portion 2012 of the first shell member 2002 (andthe second shell member 2004) can be defined by a first wall 2050, asecond wall 2052, a third wall 2054, and a fourth wall 2056. The firstwall 2050 can be relatively planar and the central longitudinal axis2014 can be normal to the first wall 2050. The second wall 2052 and thethird wall 2054 can be curved (as shown in FIGS. 69-75C). The fourthwall 2056 can be relatively planar and arranged perpendicular to thefirst wall 2050. In some embodiments, the fourth wall 2056 can define anopening (which can also be referred to herein as a window) 2046 andextend between the second wall 2052 and the third wall 2054 (e.g., in acircumferential direction or in a direction that is perpendicular to thecentral longitudinal axis 2014).

In other embodiments, as explained further below with reference to FIGS.76A and 76B, the second portion 2012 may not include the fourth wall2056 (and the opening 2046) and instead the second wall 2052 and thethird wall 2054 can be continuous with one another (e.g., forming onecontinuously curved wall, forming a complete half cylinder).

Each of the walls of the second portion 2012 can include an innersurface and an outer surface. For example, the first wall 2050 can havea first inner surface 2042, the second wall 2052 can have a second innersurface 2044, the third wall 2054 can have a third inner surface 2043,and the fourth wall 2056 can have a fourth inner surface 2048 (FIG. 70). The first inner surface 2042, the second inner surface 2044, thethird inner surface 2043, and the fourth inner surface 2048 can definethe half cavity portion 2040.

As shown in FIGS. 69 and 70 , in some embodiments, the depression 2026can extend to the first inner surface 2042. In this way, the depression2026 can be continuous from the first inner surface 2042 to a distal endof the first portion 2010.

In some embodiments, the second inner surface 2044 and the third innersurface 2043 are each curved and, together, form a half cylinder shapeof the second portion 2012. In some embodiments, the second innersurface 2044 and the first inner surface 2042 are separated from oneanother by the opening 2046 and connected together by the fourth innersurface 2048, at a proximal end of the second portion 2012.

The second portion 2012 of the first shell member 2002 (and similarly,the second shell member 2004) can further included a mating surface 2058which is configured to mate with a corresponding mating surface of thesecond shell member 2004 (as shown in FIG. 71C). The mating surface 2058can be formed along edges of the first wall 2050, the second wall 2052,and the third wall 2054.

In some embodiments, the mating surface 2058 of the second portion 2012can be continuous with (and/or in a same plane) as the inner surface2024 of the first portion 2010. In this way, the inner surface 2024 andthe mating surface 2058 can form an entire mating surface of the firstshell member 2002 or the second shell member 2004.

In some embodiments, the mating surface 2058 can be planar or relativelyplanar and include a first mating element, which in some embodiments canbe configured as a protrusion (or tongue) 2060 extending along a firstportion of the mating surface 2058 (e.g., on a first side of the matingsurface 2058, relative to the central longitudinal axis 2014) and asecond mating element, which in some embodiments can be configured as agroove (or depression) 2062 extending along a second portion of themating surface 2058 (e.g., on a second side of the mating surface 2058which is opposite the first side, relative to the central longitudinalaxis 2014). A detail view of the first portion of the mating surface2058 including the protrusion 2060 is shown in FIG. 71A and a detailview of the second portion of the mating surface 2058 including thegroove 2062 is shown in FIG. 71B. The protrusion extends outward fromthe mating surface 2058 and the groove 2062 is depressed into the matingsurface 2058.

FIG. 71C is a detail view of the mating interface 2008 between theprotrusion 2060 of the first shell member 2002 (e.g., on the firstportion of the mating surface 2058 of the first shell member 2002) andthe groove 2062 of the second shell member 2004 (e.g., on the secondportion of the mating surface 2058 of the second shell member 2004). Asshown in FIG. 71C, in some embodiments, the respective mating surfaces2058 of the respective second portions 2012 of the first shell member2002 and the second shell member 2004 can be positioned against oneanother (e.g., in face-to-face contact) and the protrusion 2060 of thefirst shell member 2002 can extend into (and interface or mate with) thegroove 2062 of the second shell member 2004. The reverse of this matingengagement can occur at the second portions of the mating surfaces 2058of the first shell member 2002 and the second shell member 2004 (e.g.,on an opposite side of the balloon cover 2000, the protrusion 2060 ofthe second shell member 2004 can extend into and interface or mate withthe groove 2062 of the first shell member 2002.

In other embodiments, the mating interface 2008 between the first shellmember 2002 and the second shell member 2004 can be configureddifferently with different interlocking or interfacing mating features(e.g., such as other lock-and-key or complementary features). In someembodiments, the mating interface 2008 between the first shell member2002 and the second shell member 2004 can have different protruding anddepressed interlocking features, such as a differently shaped protrusion(e.g., triangular in cross-section or a series of spaced apartprotrusions) and a correspondingly shaped groove(s) or depression(s).

The configuration of the mating interface 2008, as described above, canprevent the first shell member 2002 and the second shell member 2004from sliding past one another when the assembled balloon cover 2000 isgrabbed or handled by a user.

Once assembled in mating engagement (as shown in FIGS. 72-75C), thefirst shell member 2002 and the second shell member 2004 can be held orcoupled together (e.g., such that they cannot be pulled apart from oneanother) via a coupling element. In some embodiments, as shown in FIGS.69, 72, 73, and 75A, the coupling element can be configured as a sleeve2064. In some embodiments, the sleeve 2064 can be tubular and configuredto slide over and around the mated together first portions 2010 of thefirst shell member 2002 and the second shell member 2004. For example,the sleeve 2064 can be configured to hold the first shell member 2002and the second shell member 2004 in mating engagement with one another.As a result, the balloon cover 2000 can be held together (and mounted)on and around the distal end portion 309 of the delivery apparatus.

As introduced above and shown in FIGS. 72 and 73 , when assembledtogether, the first portions 2010 of the first shell member 2002 and thesecond shell member 2004 can cover and enclose therein a portion of thedistal end portion 309 of the delivery apparatus and the balloon 318. Insome embodiments, the portion of the delivery apparatus covered by thefirst portions 2010 of the balloon cover 2000 can include a portion ofthe nose cone 322, the distal shoulder 326, the valve mounting portion324, and a portion of the inner shaft 308 which the proximal end portion333 of the balloon 318 is arranged around, and the portions of theballoon 318 covering these portions of the delivery apparatus (FIG. 72).

Additionally, as shown in FIGS. 72 and 73 , when assembled together, thesecond portions 2012 of the first shell member 2002 and the second shellmember 2004 can cover and enclose therein a positioning device (e.g.,positioning device 1100) mounted on the distal end portion 309 of thedelivery apparatus, proximal to the valve mounting portion 324 of thedistal end portion 309 of the delivery apparatus.

In some embodiments, the second portions 2012 of the first shell member2002 and the second shell member 2004 can cover and enclose an entiretyof the positioning device 1100. In other embodiments, the secondportions 2012 of the first shell member 2002 and the second shell member2004 can cover and enclose a majority of the positioning device 1100(e.g., all but a proximal most portion, as shown in FIGS. 72 and 72 ).

When assembled together, the second portions 2012 of the first shellmember 2002 and the second shell member 2004 can form a closed distalend 2066 (FIGS. 72, 73, and 75A) and an open proximal end 2068 (FIGS.72-75C). For example, the closed distal end 2066 can be formed by outersurfaces 2070 of the first walls 2050 of the first shell member 2002 andthe second shell member 2004.

In other embodiments, the distal end 2066 can be at least partially openwith one or more openings or windows in the first walls 2050 of thefirst shell member 2002 and/or the second shell member 2004.

Additionally, in some embodiments (as shown in FIGS. 74-75C), the openproximal end 2068 can be formed by edge portions 2072 of the second wall2052 and the third wall 2054 of each of the first shell member 2002 andthe second shell member 2004.

In other embodiments, the proximal end 2068 can be at least partiallyclosed. For example, in such embodiments, the edge portions 2072 canextend radially inward to form partial (e.g., not fully enclosed) walls.

The first portions 2010 of the first shell member 2002 and the secondshell member 2004 extend distally, in the axial direction, from theclosed distal end 2066.

Outer surfaces of the walls of the second portions 2012 of the firstshell member 2002 and the second shell member 2004 can form the secondcover portion 2003 of the balloon cover 2000 and can provide a surfacefor a user to grab and/or hold onto when sliding the sleeve 2064 off thefirst portions 2010 (so that the balloon cover 2000 can be removed fromthe delivery apparatus).

When the second portions 2012 of the first shell member 2002 and thesecond shell member 2004 are assembled to form the second cover portion2003, a cylinder-shaped enclosure (e.g., cylinder) can be formed. Innerdimensions of the cylinder-shaped enclosure can define the cavity 2038.For example, the second cover portion 2003 can have an inner diameter2074 and an inner height 2076 (FIGS. 74 and 75B). The inner height 2076can be defined between the fourth inner surface 2048 of the fourth wall2056 of the first shell member 2002 and the fourth inner surface 2048 ofthe fourth wall 2056 of the second shell member 2004 (FIG. 74 ). Theinner diameter 2074 can be defined between oppositely arranged curvedwalls (e.g., second walls 2052, as shown in FIG. 74 ) of the first shellmember 2002 and the second shell member 2004.

As shown in FIGS. 75B and 75C, the inner diameter 2074 and the innerheight 2076 can be selected based on a largest dimension of thepositioning device to be contained within the cavity 2038. For example,the inner diameter 2074 and the inner height 2076 can be selected suchthat the flange portion 1112 of the positioning device 1100 fits withinthe cavity 2038, without touching (e.g., being spaced away from) thesecond inner surfaces 2044 and the third inner surfaces 2043 of thefirst shell member 2002 and the second shell member 2004. For example,the inner diameter 2074 can be larger than an outer diameter of theflange portion 1112.

In some embodiments, the inner height 2076 can be the same or slightlysmaller than the outer diameter of the flange portion 1112. For example,in some embodiments, as shown in FIG. 75C, one or more portions of theflange portion 1112 of the positioning device 1100 (e.g., an extensionportion 1114) can extend into one of the openings 2046 (e.g., betweenthe fourth inner surface 2048 and an outer surface of the fourth wall2056).

As such, when a user grabs onto the exterior of the second cover portion2003 (e.g., to remove the sleeve 2064), any movement of the ballooncover 2000 will not result in movement of the positioning device 1100relative to the delivery apparatus, since the balloon cover 2000 doesnot directly contact the positioning device 1100. For example, if theballoon cover 2000 is rotated, this rotation will not result in rotationof the positioning device 1100, thereby maintaining the positioningdevice in a specified and intended circumferential position relative tothe delivery apparatus. This can enable a prosthetic valve to be mountedon the valve mounting portion of the delivery apparatus in apredetermined circumferential orientation relative to a radiopaquemarker on the delivery apparatus, as discussed herein (e.g., asdiscussed above with reference to FIG. 57 ).

In some embodiments, as shown in FIGS. 74-75C, the inner height 2076 canbe smaller than the inner diameter 2074. Correspondingly, the secondcover portion 2003 can have an outer height 2078 that is smaller than anouter diameter 2080 (FIG. 75B). The reduced inner height 2076 and outerheight 2078, as compared to the corresponding diameters, of the secondcover portion 2003 can reduce an overall packaging space of the ballooncover 2000. This can reduce material costs of the balloon cover itselfand packaging materials used to contain the balloon cover. Thus, theinner diameter 2074 and the inner height 2076 can be selected to be assmall as possible to reduce packaging space, while still being largeenough to prevent engagement with the positioning device (FIG. 76C).

In some embodiments, the configuration of the openings 2046 in thefourth walls 2056 of the first shell member 2002 and the second shellmember 2004 can result in the reduced inner height 2076 and outer height2078.

In some embodiments, the openings 2046 can also allow a user tovisualize the positioning device 1100 and the distal end portion 309 ofthe delivery apparatus 300, which may allow for easier assembly of theballoon cover 2000 around the delivery apparatus.

In other embodiments, the second cover portion 2003 can be cylindricaland the first shell member 2002 and the second shell member 2004 canhave walls that fully enclose the positioning device therein, withoutany openings. For example, FIGS. 76A and 76B show another exemplaryembodiment of a balloon cover 2100 comprising a first shell member 2102and a second shell member 2104 that are configured to matingly engagewith each other and be removably coupled to each other.

The first shell member 2102 and the second shell member 2104 can beconfigured similarly to the first shell member 2002 and the second shellmember 2004 of the balloon cover 2000 (FIGS. 69-75C), except the firstshell member 2102 and the second shell member 2104 do not include anopening 2046 and an inner diameter 2106 and outer diameter 2108 of asecond cover portion 2110 (similar to second cover portion 2003) areconstant around a circumference of the second cover portion 2110 (FIG.76B). As such, the second cover portion 2110 does not have a reducedheight (as compared to the balloon cover 2000). Thus, the balloon cover2100 (FIGS. 76A and 76B) can increase packaging space as compared to theballoon cover 2000 (FIGS. 69-75C).

FIGS. 108-114 show another embodiment of a balloon cover 2600 that isconfigured to cover a portion of a distal end portion of a deliveryapparatus (e.g., distal end portion 309 of delivery apparatus 300) thatincludes an inflatable balloon (e.g., balloon 318) mounted thereon and apositioning device coupled to the distal end portion of the deliveryapparatus, proximal to a valve mounting portion of the deliveryapparatus (e.g., positioning device 1100). The balloon cover 2600 can besimilar to the balloon cover 2000 of FIGS. 69-75C, except it isconfigured to receive a portion of the positioning device and preventrotation of the positioning device and balloon cover 2600 relative toone another. For example, independent rotation between the positioningdevice and balloon cover 2600 can result in twisting of the balloon,thereby causing unpredictable rotation of the prosthetic heart valveduring valve deployment at the implantation site (and thus uncertaintyto the positioning of the prosthetic valve commissures relative to thenative valve commissures).

The balloon cover 2600 comprises a first cover portion 2601 that isconfigured to cover at least a portion of the distal end portion of thedelivery apparatus that includes the balloon and a second cover portion2603 that is configured to cover the positioning device. The ballooncover 2600 can comprise a first shell member 2602 and a second shellmember 2604 that are configured to matingly engage with each other andbe removably coupled to each other (FIGS. 110 and 113 ). For example,the first shell member 2602 and the second shell member 2604 cancomprise two halves of an outer shell 2606 of and/or forming the ballooncover 2600 (FIG. 110 ).

The outer shell 2606 and balloon cover 2600 are shown in a disassembledconfiguration in the exploded view of FIG. 110 and in an assembledconfiguration in the various views of FIGS. 108, 109, 111, and 113 .Further, FIG. 113 shows a cross-sectional view of the balloon cover 2600while FIG. 114 shows one of the shell members (e.g. first shell member2602) arranged around the delivery apparatus.

In some embodiments, the first shell member 2602 and the second shellmember 2604 can have a similar or same mating interface 2008 as thatdescribed above with reference to FIGS. 71A-71C.

Each of the first shell member 2602 and the second shell member 2604includes a first portion (e.g., first shell portion) 2610 and a secondportion (e.g., second shell portion) 2612. In some embodiments, thefirst portion 2610 and the second portion 2612 of one of the first shellmember 2602 and the second shell member 2604 can be continuous with oneanother (e.g., formed as one piece). Similar to the balloon cover 2000,the second portion 2612 of the balloon cover 2600 can have a largerwidth than the first portion 2610.

When the first shell member 2602 and the second shell member 2604 areassembled together (e.g., in mating engagement), the first portions 2610of the first shell member 2602 and the second shell member 2604 can formthe first cover portion 2601 and define an elongate cavity 2620 (FIGS.110 and 113 ). The cavity 2620 can be configured to receive a distal endportion of a delivery apparatus and at least a portion of a balloon(e.g., a majority portion in some embodiments) mounted on the distal endportion of the delivery apparatus (e.g., balloon 318 of the distal endportion 309, as shown in FIGS. 110, 113, and 114 ).

For example, the first portion 2610 of the first shell member 2602 (andsimilarly, the second shell member 2604) comprises an outer (radiallyoutward facing) surface 2622 (FIGS. 110, 112, and 113 ) and an inner(radially inward facing) surface 2624 (FIGS. 110 and 114 ). The innersurface 2624 can be a mating surface that is configured to mate with ormatingly engage with (e.g., have face-to-face contact with) a respectiveinner surface of the first portion 2610 of the other (e.g., second)shell member forming the balloon cover 2600. In some embodiments, theinner surface 2624 can be a planar surface.

In some embodiments, the first portion 2610 of one of the shell members(the second shell member 2604, as shown in FIGS. 110 and 112 ) caninclude an aperture or window 2660 disposed through the outer surface2622 and the inner surface 2624 and positioned such that the marker 600on the distal shoulder (or other marker on the distal end portion of thedelivery apparatus) can be visualized by a user when the balloon coveris coupled to the delivery apparatus, as described herein.

The first portion 2610 can further include a depression 2626 which isdepressed into the inner surface 2624 (toward the outer surface 2622,FIGS. 110 and 114 ). Together, the depressions 2626 of the first shellmember 2602 and the second shell member 2604 can form the cavity 2620.

Each depression 2626 can be shaped to receive a portion of the distalend portion 309 of the delivery apparatus. For example, each depression2626 can include a distal section 2628 and a proximal section 2630 (FIG.110 ). In some embodiments, the distal section 2628 can be shaped (e.g.,configured) to receive the balloon (e.g., balloon 318) and the portionof the delivery apparatus which the balloon overlays. For example, inthe embodiment shown in FIGS. 108-114 , the distal section 2628 can beshaped to receive a portion of the nose cone 322 and the distal endportion 332 of the balloon 318 which overlays the distal shoulder 326 ofthe delivery apparatus 300 (FIGS. 110, 113, and 114 ).

In some embodiments, the proximal section 2630 can be shaped (e.g.,configured) to receive the intermediate portion 335 of the balloon andthe portion of the delivery apparatus 300 which the intermediate portion335 overlays (e.g., the valve mounting portion 324). In someembodiments, the proximal section 2630 can also be shaped to receive atleast a distal portion of the proximal end portion 333 of the balloon318, but in the embodiment shown in FIGS. 108-114 , the proximal endportion 333 of the balloon 318 can have a same profile or diameter asthe intermediate portion 335. Thus, the proximal section 2630 can have aconstant or relatively constant width along its length (or a majority ofits length), from the distal section 2628 to the second portion 2612 ofthe shell member. In other embodiments, each depression 2626 can beshaped similar to the depression 2026 of the balloon cover 2000 shown inFIGS. 69-75C.

In this way, a shape or contour of the depression 2626 can vary along alength of the first portion 2610. For example, as shown in FIGS. 110,113, and 114 , the proximal section 2630 is narrower than the distalsection 2628.

In some embodiments, the length of the first portion 2610 can be longerthan a length of the second portion 2612, as described above withreference to FIGS. 69-75C.

The second portion 2012 of each of the first shell member 2602 and thesecond shell member 2604 can be configured (sized and shaped) based on alength and/or size of the positioning device (e.g., positioning device1100) to be contained within the second portions 2612 of the first shellmember 2602 and the second shell member 2604 when they are coupledtogether in mating engagement.

When the first shell member 2602 and the second shell member 2604 areassembled to one another (e.g., coupled together in mating engagement),the second portions 2612 of the first shell member 2602 and the secondshell member 2604 can form the second cover portion 2603 and define acavity 2638 (FIGS. 108 and 111-114 ). The cavity 2638 can be configuredto receive a positioning device (e.g., positioning device 1100, as shownin FIGS. 108-114 ) mounted on the distal end portion 309 of the deliveryapparatus 300, proximal to a valve mounting portion 324 of the distalend portion 309. In some embodiments, the overall dimensions of thecavity 2638, apart from the one or more cavities 2652 described furtherbelow, can be similar to the cavity 2038 of the balloon cover 2000, asdescribed above.

Similar to the balloon cover 2000 (FIGS. 69-75C), inner surfaces ofwalls of the second portion 2612 can define one half cavity portion ofthe cavity 2638. In some embodiments, the second portion 2612 of thesecond shell member 2604 can be configured the same or similar to thesecond portion 2012 of the first and second shell members 2002 and 2004of the balloon cover 2000 (see description of FIGS. 69-75C above).However, the second portion 2612 of the first shell member 2602 can havea first wall 2650 (the wall connecting to the first portion 2610) thatis shaped (e.g., keyed) to receive a portion of the positioning device1100. For example, the first wall 2650 of the second portion 2612 of thefirst shell member 2602 can be shaped to form one or more cavities 2652that are shaped to receive and hold therein a portion of the flangeportion 1112 of the positioning device 1100 (FIGS. 110, 113, and 114 ).In some embodiments, the second portion 2612 of the first shell member2602 can comprise one or more protruding wall portions 2654 that arepart of or extend from the first wall 2650 to protrude into the cavity2638 and form the one or more cavities 2652 (FIGS. 108, 110, 113, and114 ).

By configuring the first wall 2650 of the second portion 2612 of thefirst shell member 2602 to have the one or more cavities 2652, when theballoon cover 2600 is coupled to the delivery apparatus and around thepositioning device 1100, the positioning device 1100 and balloon cover2600 are prevented from rotating relative to one another. As a result,twisting of the balloon 318 can be avoided.

In some embodiments, one of the shell portions of any of the otherballoon covers described herein (e.g., with reference to FIGS. 69-86 )can have a second portion comprising one or more cavities 2652 that areshaped to receive and hold therein a portion of the flange portion 1112of the positioning device 1100, as described above with reference toFIGS. 108-114 .

Returning to FIGS. 108-114 , remaining walls of the second portion 2612of the first shell member 2602 can be similar to the walls of the secondshell member 2604. As described above with reference to the ballooncover 2000, the second portions 2612 of the balloon cover 2600 candefine openings 2646.

Once assembled in mating engagement (as shown in FIGS. 108, 109, and111-113 ), the first shell member 2602 and the second shell member 2604can be held or coupled together (e.g., such that they cannot be pulledapart from one another) via a coupling element. In some embodiments, thecoupling element can be configured as a sleeve 2664. The sleeve 2664 canbe configured the same or similar to the sleeve 2064 of the ballooncover 2000.

As introduced above, when assembled together, the first portions 2610 ofthe first shell member 2602 and the second shell member 2604 can coverand enclose therein a portion of the distal end portion 309 of thedelivery apparatus and the balloon 318 (FIGS. 108, 109, and 111-114 ).In some embodiments, the portion of the delivery apparatus covered bythe first portions 2610 of the balloon cover 2600 can include a portionof the nose cone 322, the distal shoulder 326, the valve mountingportion 324, and a portion of the inner shaft 308, and the portions ofthe balloon 318 covering these portions of the delivery apparatus (FIGS.113 and 114 ).

Similar to as described above with reference to FIGS. 69-75C, outersurfaces of the walls of the second portions 2612 of the first shellmember 2602 and the second shell member 2604 can form the second coverportion 2603 of the balloon cover 2600 and can provide a surface for auser to grab and/or hold onto when sliding the sleeve 2664 off the firstportions 2610 (so that the balloon cover 2600 can be removed from thedelivery apparatus), without grabbing onto the positioning device 1100.

As introduced above with reference to FIGS. 38-41 , the distal endportion 309 of the delivery apparatus 300 can include a distal tipportion 900 mounted on or disposed at the distal end of the outer shaft304. In some embodiments, after mounting the prosthetic valve in aradially compressed state around the valve mounting portion 324 of thedelivery apparatus 300, the outer shaft 304 and the intermediate shaft(e.g., balloon shaft) 306 can be moved axially relative to one anothersuch that the distal tip portion 900 is arranged over the proximal endportion 333 of the balloon 318. As a result, the distal tip portion 900can act as a proximal shoulder on a proximal side of the valve mountingportion 324 and resist movement of the radially compressed prostheticvalve, proximally in the axial direction, during advancing the distalend portion of the delivery apparatus to the target implantation site.

As previously described, prior to crimping the prosthetic valve aroundthe valve mounting portion 324, the balloon 318 can undergo a cyclicde-airing process whereby the inflation fluid is introduced into theballoon and then withdrawn from the balloon. The process of introducinginflation fluid into the balloon 318 and then withdrawing the inflationfluid can be repeated one or more times as needed. During the de-airingprocess, the distal tip portion 900 is typically positioned proximal tothe balloon 318 (e.g., off and away from the proximal end portion 333 ofthe balloon 318) to facilitate the flow of inflation fluid into theproximal end portion 333 of the balloon 318. In some embodiments, thede-airing process can be carried out while the balloon 318 is containedwithin a balloon cover. Following the de-airing process, the ballooncover can be removed from the balloon and the outer shaft 304 can bemoved axially relative to the intermediate shaft 306 (and the innershaft 308) to a more distal position extending over the proximal endportion 333 of the balloon 318 (as shown in FIG. 41 ). When the distaltip portion 900 is moved distally over the proximal end portion 333,residual fluid in the proximal end portion 333 of the balloon from thede-airing process can be pushed distally into the intermediate portion335 and the distal end portion 332 of the balloon 318.

As introduced above, in order to accommodate this residual fluid withoutincreasing a crimping profile of the prosthetic valve on the deliveryapparatus, a radial depression 334 can be initially formed in the distalend portion 332 of the balloon 318 (e.g., prior to moving the distal tipportion 900 over the proximal end portion 333 of the balloon 328, FIG.40 ). When the residual inflation fluid in the proximal end portion 333of the balloon 318 is “squeezed” or pushed into the distal end portion332 of the balloon 318 by advancing the distal tip portion 900, thedisplaced residual fluid can dilate the distal end portion 332 of theballoon 318 from the radially depressed state shown in FIG. 40 to theexpanded state 924 shown in FIG. 41 (and shown with dashed lines in FIG.40 ). As a result, undesirable inflation of the intermediate portion324, which can thereby expand a crimping profile of the prostheticvalve, can be avoided.

Various techniques and mechanisms can be used to achieve the balloonshape shown in FIG. 40 , including a balloon cover having an internalcavity that is shaped to produce the desired shape of the balloon (e.g.,the radial depression 334).

FIGS. 77-83B show an exemplary embodiment of a balloon cover 2200 thatis configured to receive (and cover) a portion of a distal end portionof a delivery apparatus (e.g., distal end portion 309 of deliveryapparatus 300, as shown in FIG. 77 ) that includes an inflatable balloon(e.g., balloon 318) mounted thereon. In some embodiments, the ballooncover 2200 is configured to additionally receive a positioning devicecoupled to the distal end portion of the delivery apparatus, proximal toa valve mounting portion of the delivery apparatus (e.g., positioningdevice 1100, as shown in FIGS. 53-55 and 77 ).

More specifically, the balloon cover 2200 is configured to receive andcreate a specified, final shape of the balloon 318 (e.g., such as theshape shown in FIG. 40 , which includes the radial depression 334). Forexample, FIG. 77 is an exploded view of the balloon cover 2200configured to be assembled around the distal end portion 309 of thedelivery apparatus 300.

Cross-sectional views of the assembled balloon cover 2200 are shown inFIGS. 83A and 83B. As described more fully below, the balloon cover 2200can be similar to the balloon cover 2100 described above with referenceto FIGS. 69-75C, except for the addition of a depression sleeve that isconfigured to receive the distal end portion 332 of the balloon 318 anda first cavity (formed by depressions of the shell members) that isconfigured to receive the intermediate portion 335 and the proximal endportion 333 of the balloon 318.

As shown in FIGS. 77 and 83A, the balloon cover (or balloon coverassembly) 2200 comprises a first cover portion 2201 that is configuredto cover at least a portion of the distal end portion of the deliveryapparatus that includes the balloon. The balloon cover 2200 can furthercomprise a second cover portion 2203 that is configured to cover thepositioning device (FIGS. 77 and 83A).

The balloon cover 2200 can comprise a first shell member 2202 and asecond shell member 2204 that are configured to matingly engage witheach other and be removably coupled to each other (similar to the firstshell member 2002 and the second shell member 2004 of the balloon cover2000). For example, the first shell member 2202 and the second shellmember 2204 can comprise two halves of a shell 2206 of the balloon cover2200 (FIGS. 77, 83A, and 83B).

The balloon cover 2200 can further comprise a depression sleeve 2240(which can also be referred to as a depression cap, member, or tube).The depression sleeve 2240 can be configured to form a shape (e.g., anindented or depressed shape) of a portion of a balloon of the deliveryapparatus (e.g., the radial depression 334 in the distal end portion 332of the balloon 318). The depression sleeve 2240 is described in furtherdetail below with reference to the various views of FIGS. 78-81B.

In some embodiments, the balloon cover 2200 can further comprise acoupling element, which in some embodiments can be a tubular sleeve(e.g., outer sleeve) 2264, which is configured to cover at least aportion of the depress sleeve 2240 and depress one or more depressionmembers 2256 of the depression sleeve 2240 in a radially inwarddirection, toward the central longitudinal axis 2214, in order to form anegative depression in one or more portions of the balloon.

In some embodiments, the sleeve 2264 can be additionally configured tohold the first shell member 2202 and the second shell member 2204 inmating engagement with one another (e.g., as shown in FIGS. 83A and83B). The sleeve 2264 can be the same or similar to the sleeve 2064, asdescribed above.

The balloon cover 2200 is shown in a disassembled configuration in theexploded view of FIG. 77 and in an assembled configuration in thevarious views of FIGS. 83A and 83B. FIG. 82 shows the first shell member2202 disassembled from a remainder of the balloon cover 2200.

However, since in some embodiments the first shell member 2202 and thesecond shell member 2204 can be configured the same (e.g., identicallyformed), the first shell member shown in FIG. 82 may alternatively bethe second shell member 2204. Additionally, FIGS. 78-81B show differentviews of the depression sleeve 2240 alone.

As shown in FIGS. 77 and 82 , in some embodiments, each of the firstshell member 2202 and the second shell member 2204 includes a firstportion (e.g., first shell portion) 2210 and a second portion (e.g.,second shell portion) 2212. In some embodiments, for each of the firstshell member 2202 and the second shell member 2204, the first portion2210 and the second portion 2212 can be continuous with one another.

In some embodiments, the second portion 2212 can have a second width2218 that is larger than a first width 2216 of the first portion 2210,the widths defined in a radial direction relative to a centrallongitudinal axis 2214 of the balloon cover 2200 (which can be coaxialwith a central longitudinal axis of the delivery apparatus whenassembled and coupled around the delivery apparatus). In someembodiments, the first width 2216 and the second width 2218 can bediameters.

When the first shell member 2202 and the second shell member 2204 areassembled together (e.g., in mating engagement), the first portions 2210of the first shell member 2202 and the second shell member 2204 can forma portion of the first cover portion 2201 (e.g., which also includes thedepression sleeve 2240, as described further below) and define anelongate cavity 2220 (which, in some embodiments can be referred to as alumen). The cavity 2220 (FIGS. 77, 83A, and 83B) can be configured toreceive a distal end portion of a delivery apparatus and at least aportion of a balloon (e.g., an intermediate portion and proximal endportion in some embodiments) mounted on the distal end portion of thedelivery apparatus (e.g., balloon 318 of the distal end portion 309, asshown in FIG. 77 ).

For example, the first portion 2210 of the first shell member 2202 (andsimilarly, the second shell member 2204) comprises an outer surface 2222and an inner surface 2224 (FIGS. 77 and 82 ). The inner surface 2224 canbe a mating surface that is configured to mate with or matingly engagewith (e.g., have face-to-face contact with) a respective inner surfaceof the first portion 2210 of the other (e.g., second) shell memberforming the balloon cover 2200. In some embodiments, the inner surface2224 can be a planar surface.

The first portion 2210 can further include a depression 2226 which isdepressed into the inner surface 2224, toward the outer surface 2222(FIG. 82 ). Together, the depressions 2226 of the first shell member2202 and the second shell member 2204 can form the cavity 2220 (FIGS.77, 83A, and 83B). Thus, each depression 2226 of each of the first shellmember 2202 and the second shell member 2204 can define a half cavityportion 2221 of the cavity 2220 (FIG. 82 ).

Each depression 2226 can be shaped to receive a portion of the distalend portion 309 of the delivery apparatus (e.g., a portion of thedelivery apparatus which the intermediate and proximal end portions ofthe balloon 318 overlay). For example, each depression 2226 can includea proximal section 2230 and an intermediate section 2232 (FIG. 82 ). Insome embodiments, the depressions 2226 of the balloon cover 2200 can besimilar to the depressions 2026 of the balloon cover 2000 (FIG. 70 ),except the depressions 2226 do not include a distal section configuredto receive the distal end portion 332 of the balloon 318.

For example, in some embodiments, the intermediate section 2232 can beshaped (e.g., configured) to receive the intermediate portion 335 of theballoon and the portion of the delivery apparatus 300 which theintermediate portion 335 overlays (e.g., the valve mounting portion324).

In some embodiments, the proximal section 2230 can be shaped (e.g.,configured) to receive at least a distal portion of the proximal endportion 333 of the balloon 318. In some embodiments, a more proximalportion of the proximal end portion 333 of the balloon 318 can extendinto the second portion 2212 of the first shell member 2202 or thesecond shell member 2204. In other embodiments, the proximal section2230 can be shaped to receive an entirety of the proximal end portion333 of the balloon 318.

In this way, a shape or contour of the depression 2226 can vary along afirst length 2234 of the first portion 2210, the first length 2234extending in an axial direction relative to the central longitudinalaxis 2214 (FIG. 82 ). For example, as shown in FIG. 82 , theintermediate section 2232 can be narrower than the proximal section2030. In some embodiments, a width of the intermediate section 2232 isconstant along a majority of a length of the intermediate section 2232.

In some embodiments, the first length 2234 of the first portion 2210 canbe longer than a second length 2236 of the second portion 2212 (FIG. 82).

In other embodiments, the second length 2236 of the second portion 2212can be the same or longer than the first length 2234 of the firstportion 2210.

In some embodiments, the second length 2236 of the second portion 2212can be selected based on a length and/or size of the positioning device(e.g., positioning device 1100) to be contained within the secondportions 2212 of the first shell member 2202 and the second shell member2204 when they are coupled together in mating engagement. For example,in some embodiments, the second length 2236 can be the same or longerthan a length of the positioning device 1100. In some embodiments, thesecond length 2236 can be shorter than a length of the positioningdevice 1100, but long enough to cover enough of the positioning device(e.g., a majority portion or wider or larger diameter portions of thepositioning device) such that a user is blocked or deterred fromgrabbing onto the positioning device 1100.

When the first shell member 2202 and the second shell member 2204 areassembled to one another (e.g., coupled together in mating engagement),the second portions 2212 of the first shell member 2202 and the secondshell member 2204 can form the second cover portion 2203 and define thecavity 2038 (FIGS. 83A and 83B). As described above with reference toFIGS. 69-75C, the cavity 2038 can be configured to receive a positioningdevice (e.g., positioning device 1100 shown in FIG. 77 ) mounted on thedistal end portion 309 of the delivery apparatus 300, proximal to avalve mounting portion 324 of the distal end portion 309.

The second portion 2212 of each of the first shell member 2202 and thesecond shell member 2204 can be configured similarly to (or the same as)the second portion 2012 of each of the first shell member 2002 and thesecond shell member 2004 of the balloon cover 2000, as described abovewith reference to FIGS. 69-75C. Thus, similar components have beenlabeled similarly in FIGS. 77-83B.

For example, in some embodiments, the walls and inner and outer surfacesof the second portion 2212 can be configured the same is in the secondportion 2012 (and thus, are labeled accordingly in FIGS. 77-83B).Further, the second portion 2212 can include the mating surface 2058with the first mating element (e.g., protrusion 2060) and the secondmating element (e.g., groove 2062). In this way, the second portions2212 of the first shell member 2202 and the second shell member 2204 canbe configured to matingly engage with each other in the same way asdescribed above for balloon cover 2000 (e.g., as described above withreference to FIG. 71C).

As shown in FIGS. 77 and 82-83B, in some embodiments, the depression2226 can extend to the first inner surface 2042. In this way, thedepression 2226 can be continuous from the first inner surface 2042 to adistal end of the first portion 2210.

When assembled together, the first portions 2210 of the first shellmember 2202 and the second shell member 2204 can cover and enclosetherein a portion of the distal end portion 309 of the deliveryapparatus and the balloon 318. In some embodiments, the portion of thedelivery apparatus covered by the first portions 2210 of the ballooncover 2200 can include the valve mounting portion 324 and a portion ofthe inner shaft 308 which the proximal end portion 333 of the balloon318 is arranged around, and the portions of the balloon 318 coveringthese portions of the delivery apparatus (FIGS. 77, 83A, and 83B).

Additionally, similar to as described above for the balloon cover 2000(FIGS. 69 and 72-75C), when assembled together, the second portions 2212of the first shell member 2202 and the second shell member 2204 cancover and enclose therein a positioning device (e.g., positioning device1100) mounted on the distal end portion 309 of the delivery apparatus,proximal to the valve mounting portion 324 of the distal end portion 309of the delivery apparatus.

In some embodiments, the second cover portion 2203 and the cavity 2038can have the same or similar dimensions (e.g., inner and outer diametersand heights) to those described above with reference to the ballooncover 2000.

As introduced above, the balloon cover 2200 can further comprise thedepression sleeve 2240 which is configured to form a negative depressionin one or more portions of the balloon 318. For example, in someembodiments (as shown in FIGS. 77-83B), the depression sleeve 2240 canbe configured to form a negative radial depression in the distal endportion 332 of the balloon 318 (e.g., the radial depression 334).

In other embodiments, the depression sleeve 2240 can be configured toform a depression in an alternate portion of the balloon (e.g., theintermediate portion of the proximal end portion). In these embodiments,the depression sleeve 2240 and the first portions 2210 of the firstshell member 2202 and the second shell member 2204 can be modified suchthat the depression sleeve 2240 covers the alternate portion(s) of theballoon when the balloon cover is assembled around the deliveryapparatus. In some embodiments, the depression sleeve 2240 can beconfigured to form one or more depressions in one or more locationsalong a length of the balloon (e.g., in the distal end portion 332 andthe proximal end portion 333). In this way, a geometry of the depressionsleeve 2240 and the first portions 2210 can be selected based on aspecified geometry of the balloon which the balloon cover 2200 isconfigured to cover and at least partially shape.

As shown in FIGS. 77-81B, the depression sleeve 2240 can comprise afirst portion 2242, a second portion 2244, and a third portion 2246, thesecond portion 2244 disposed between the first portion 2242 and thethird portion 2246. In some embodiments, the first portion 2242 can be adistal end portion of the depression sleeve 2240 and can extend from adistal end (or first end) 2248 of the depression sleeve 2240 to thesecond portion 2244. In some embodiments, the third portion 2246 can bea proximal end portion of the depression sleeve 2240 and can extend froma proximal end (or second end) 2250 of the depression sleeve 2240 to thesecond portion 2244.

In some embodiments, the first portion 2242 can be configured to receivea distal portion of the delivery apparatus, such as a distal end portionof a distal shoulder (e.g., distal shoulder 226) and/or a portion of anose cone (e.g., nose cone 322). An inner diameter and/or length (in theaxial direction) of the first portion 2242 can be configured (e.g.,sized) to receive the distal end portion of the delivery apparatus whichis distal to the depressed portion of the balloon (e.g., distal to theradial depression 334).

In some embodiments, an inner lumen 2254 of the first portion 2242,defined by an inner surface of the first portion 2242), can have a firstlumen portion with a relative constant inner diameter 2251 and a secondlumen portion with an inner diameter 2253 that can increase from thefirst lumen portion to the second portion 2244 of the depression sleeve2240 (FIG. 81A).

In some embodiments, the first portion 2242 is tapered and can have anouter diameter 2252 (FIG. 81A) that tapers (e.g., decreases) from itsproximal end (at or which connects to the second portion 2244) to thedistal end 2248.

The second portion 2244 can also be referred to herein as a depressionportion of the depression sleeve 2240. The second portion 2244 cancomprise one or more depression members 2256 (FIGS. 78-81 i). In someembodiments, the second portion 2244 can include multiple (e.g., two ormore) depression members 2256 spaced apart from one another around acircumference of the second portion 2244. In some embodiments, as shownin FIGS. 78-83B, the second portion 2244 includes four depressionmembers 2256. However, in alternate embodiments, the second portion 2244can includer more or fewer than four depression members 2256 (e.g., suchas two, three, five, six, or the like).

Each depression member 2256 can have an attached end 2258 that isattached to and/or integral with a remainder of the second portion 2244and/or the third portion 2246 (FIGS. 78, 81A, and 81 ). Each depressionmember 2256 can also have a free end 2260 that is unattached to theremainder of the second portion 2244 and any other portion of thedepression sleeve 2240 (e.g., such as the first portion 2242). In thisway, the free end 2260 of the depression member 2256 can freely move andcan be configured to bend, flex, or deflect radially inward toward thecentral longitudinal axis 2214 (e.g., in response to inward pressureapplied to the free end 2260, as described further below with referenceto FIGS. 81B, 83A, and 83B).

In some embodiments, each depression member 2256 can be an elongatemember extending in the axial direction from the attached end 2258 tothe free end 2260. In some embodiments, the attached end 2258 can becoupled to and/or continuous with a wall 2262 of the third portion 2246(FIGS. 78, 81A, and 81 ). Additionally, in some embodiments, the wall2262 of the third portion 2246 can be continuous with a wall 2266 of thesecond portion 2244 (FIGS. 78 and 81A). Further, in some embodiments,the wall 2266 of the second portion 2244 can be continuous with a wall2268 of the first portion 2242 (FIGS. 78 and 81A). In this way, thefirst portion 2242, second portion 2244, and third portion 2246 of thedepression sleeve 2240 can all be continuously formed with each other(e.g., formed or molded together as one piece).

In other embodiments, one or more of the first portion 2242, secondportion 2244, and third portion 2246 of the depression sleeve 2240 canbe formed separately and attached (e.g., via mechanical or chemicalbonding) to a remainder of the portions of the depression sleeve 2240.

Each depression member 2256 can be disposed within an opening 2255formed in the wall 2266 of the second portion 2244 (FIGS. 78, 81A, and81 ). For example, side edges 2257 and the free end 2260 of eachdepression member 2256 can be spaced away from (e.g., and non-contactingwith) surfaces of the wall 2266 that define the corresponding opening2255. In this way, in some embodiments, each depression member 2256 canbe configured as a cantilever.

Each depression member 2256 can include an outer surface 2270 and aninner surface 2272 (where the outer surface 2270 and the inner surface2272 are relative to an interior of the depression sleeve 2240). In someembodiments, the outer surface 2270 can be a relatively planar outersurface, except for a protrusion (e.g., bump or outer protrusion) 2274disposed at, adjacent to, or proximate to its free end 2260 (FIGS. 78,79, 81A, and 81 ). For example, as shown in FIG. 81A, the protrusion2274 can extend radially outward (away from the central longitudinalaxis 2214) relative to a remainder of (e.g., the planar portion) of theouter surface 2270. Further, when the depression members 2256 are in thestate or configuration shown in FIG. 81A (e.g., an unbiased, unflexed,undeflected, or relaxed state, as described further below), theprotrusion 2274 can extend radially outward relative to an outer surfaceof the wall 2262 and an outer surface of the wall 2268.

In some embodiments, the inner surface 2272 can be contoured along itsaxial length (e.g., between the attached end 2258 and the free end2260). For example, the inner surface 2272 can extend further radiallyinward (toward the central longitudinal axis 2214) along its axiallength, from the attached end 2258 to a location proximate to (e.g.,adjacent to) the free end 2260. For example, the inner surface 2272 caninclude a protrusion (e.g., inner protrusion) 2276 disposed proximate toand/or adjacent to the free end 2260. In some embodiments, theprotrusion 2276 can be additionally disposed at a same or similar axialposition as the protrusion 2274 in the outer surface 2270 (FIGS. 81A and81 ).

The protrusion 2276 can be configured as a bump, extension member, rib,or the like.

For example, the protrusion 2276 can extend radially inward, toward thecentral longitudinal axis 2214, relative to a remainder of the innersurface 2272. The inner surface 2272 can slope radially inward from theattached end 2258, to the protrusion 2276. In this way, a thickness orwidth of the depression member 2256 (e.g., in the radial direction) canbe largest at the axial location of the protrusion 2276 (and protrusion2274).

In some embodiments, a shape and/or contour of the inner surface 2272,including the protrusion 2276, can be configured based on a specified,final shape of a portion of the balloon (e.g., balloon 318) which it isconfigured to cover and surround. For example, in some embodiments (asshown in FIGS. 77-83B), the inner surface 2272 can be shaped accordingto a specified final shape or contour of the distal end portion 332 ofthe balloon 318 (e.g., as shown in FIG. 40 ). For example, in someembodiments, the shape and/or contour of the inner surface 2272,including dimensions of the protrusion 2276, can be selected to form thenegative radial depression 334 in the distal end portion 332 of theballoon 318 (or, in other embodiment, a negative radial depression inanother or additional portion of the balloon).

In some embodiments, an inner lumen 2278, configured to receive thedistal end portion 332 of the balloon therein, can be formed by theinner surface 2272 of the depression members 2256 and a remaining innersurface of the second portion 2244 (e.g., the inner surface between thedepression members 2256).

The third portion 2246 can configured to receive at least a portion ofthe first portions 2210 of the first shell member 2202 and the secondshell member 2204 (e.g., when the first shell member 2002 and the secondshell member 2204 are assembled together in mating engagement with eachother). For example, in some embodiments, the third portion 2246 can beconfigured as a sleeve or shell member that is configured to fit aroundand couple to the first portions 2210 of the first shell member 2202 andthe second shell member 2204.

In some embodiments, the wall 2262 of the third portion 2246 can have anouter surface 2280 and an inner surface 2282 (FIGS. 81A and 81 ). Theouter surface 2280 can be relatively planar and configured to receivethe sleeve 2264 thereon. The inner surface 2282 can be relatively planarand define a lumen 2284 with an inner diameter 2286. In someembodiments, the inner diameter 2286 can be slightly larger than and/orsimilar to the first width 2216 of the first portions 2210.

In some embodiments, the third portion 2246 can include a flangedportion 2288 at the proximal end 2250 (FIGS. 78, 80, 81A, and 81B) thatis configured to interface (e.g., mate or couple) with correspondingretaining elements 2290 in the first portions 2210 of the first shellmember 2202 and the second shell member 2204 (FIGS. 82, 83A, and 83B).For example, in some embodiments, the flanged portion 2288 can includeone or more protrusions 2292 that extend radially inward (toward thecentral longitudinal axis 2214) and are configured to mate with thecorresponding retaining elements 2290 (FIGS. 78 and 80-81 i).

In some embodiments, the retaining elements 2290 can be configured asnotches or depressions in the outer surface 2222 (e.g., which depressinward toward the central longitudinal axis). The retaining elements2290 can be shaped to receive a corresponding protrusion 2292.

In some embodiments, the proximal end of the third portion 2246 caninclude one or more axially extending slots 2294 spaced apart around acircumference of the third portion 2246 (FIGS. 78 and 80-81 i). Eachslot 2294 can extend from the proximal end 2250 and the flanged portion2288, toward the second portion 2244. In some embodiments, the slots2294 can increase a flexibility of the flanged portion 2288 such thatthe protrusions 2292 of the flanged portion 2288 can slide axially overthe outer surface 2222 and extend (e.g., snap or couple) into thecorresponding retaining elements 2290 in the first portions 2210 of thefirst shell member 2202 and the second shell member 2204.

Additionally, in some embodiments, the first portions 2210 of the firstshell member 2202 and the second shell member 2204 can include a step2296 between a smaller width portion 2295 and a larger width (e.g.,stepped) portion 2298 of the respective first portion 2210 (FIG. 82 ).The step 2296 can be configured to receive the proximal end 2250 of thedepression sleeve 2240.

Once the first shell member 2202 and the second shell member 2204 areassembled in mating engagement with each other (as shown in FIGS. 83Aand 83B), the depression sleeve 2240 can be slid over the outer surfaces2222 of the smaller width portions 2295 of the first portions 2210 ofthe first shell member 2202 and the second shell member 2204, until theproximal end 2250 hits the steps 2296. In this configuration, the outersurface 2280 of the third portion 2246 can be relatively planar andflush with an outer surface of the larger width portion 2298 of thefirst portions 2210 (FIG. 83B).

In some embodiments, the first shell member 2202 and the second shellmember 2204 can be held or coupled together (e.g., such that they cannotbe pulled apart from one another) via the depression sleeve 2240.

When the depression sleeve 2240 is coupled to the first shell member2202 and the second shell member 2204, as described above, thedepression members 2256 can be in the relaxed or undeflected state shownin FIG. 81A (e.g., not depressed radially inward toward the centrallongitudinal axis 2214).

In some embodiments, an additional coupling element, such as the sleeve2264 (FIGS. 77, 83A, and 83B) can be slid over and around the depressionsleeve 2240. In some embodiments, the sleeve 2264 can also be arrangedaround the larger width portion 2298 of the first portions 2210 of thefirst shell member 2202 and the second shell member 2204.

When the sleeve 2264 is slid over and around the depression sleeve 2240,to the position shown in FIGS. 83A and 83B, for example, the free end2260 of each depression member 2256 is pressed radially inward, towardthe central longitudinal axis 2214, as shown in FIG. 81B. Morespecifically, as the sleeve 2264 slides over and past the first portion2242 of the depression sleeve 2240, the sleeve 2264 can come intocontact with the free end 2260 of each depression member 2256 of thesecond portion 2244. As the sleeve 2264 continues to slide along eachdepression member 2256, an inner surface of the sleeve can contact andexert a radially inward pressure on the protrusions 2274, therebycausing the free ends 2260 to bend radially inward and the protrusions2276 to extend radially inward. Once the sleeve 2264 is in place overand around the depression sleeve 2240 (FIGS. 83A and 83B), thedepression members 2256 are held in the flexed (e.g., bent or deflected)and radially inward configuration shown in FIG. 81B.

In other embodiments, an alternate coupling element (instead of thesleeve 2264) can be slid, coupled, or clamped around the depressionmembers 2256 of the depression sleeve 2240 and configured to depress ordeflect the free ends 2260 of the depression members 2256 radiallyinward, as explained above. Such a coupling element may comprise a ring,c-clamp, or the like.

In some embodiments, the outer surface 2270 of each depression member2256 can be sloped from the free end 2260 to a peak of the protrusion2274. As a result, the sleeve 2264 can be more smoothly advanced overthe protrusions 2274, toward the proximal end 2250 of the depressionsleeve 2240. When the sleeve 2264 is arranged over the second portion2244 (and the entire depression sleeve 2240), as shown in FIGS. 83A and83B, an inner surface 2265 of the sleeve 2264 contacts the protrusions2274

In this way, the depression members 2256 of the depression sleeve 2240are configured to move from an unflexed or resting configuration orstate (FIG. 81A) to the flexed or radially inward configuration or state(FIG. 81 ). In the resting configuration (FIG. 81A), the protrusions2274 of the depression members 2256 are disposed radially outwardrelative to a remainder of the outer surfaces 2270 of the depressionmembers 2256 and the outer surface 2280 of the third portion 2246. Inthis configuration, the inner protrusions 2276 of the depression members2256 are positioned further away from the central longitudinal axis2214.

In the flexed configuration (FIG. 81B), the protrusions 2274 of thedepression members 2256 and pressed radially inward by the sleeve 2264and the protrusions 2274 are disposed approximately at a same radialposition (e.g., flush with) the outer surface 2280 of the third portion2246 (e.g., due to the sleeve extend across the entire outer surface ofthe depression sleeve 2240). Further, in this configuration, since thefree ends 2260 of the depression members 2256 are deflected radiallyinward, the inner protrusions 2276 of the depression members 2256 arepositioned closer to the central longitudinal axis (as compared to theirposition in FIG. 81A). As such, when a portion of a folded balloon(e.g., the distal end portion 332 of the balloon 318) is covered by anddisposed within the inner lumen 2278 of the second portion 2244 of thedepression sleeve 2240, the protrusions 2276 can press radially inwardagainst the balloon and form a negative radial depression in the portionof the balloon (e.g., the radial depression 334 shown in FIG. 40 ).

In this way, the balloon cover 2200 including the depression sleeve 2240illustrated in FIGS. 77-83B can be configured to cover a distal endportion of a delivery apparatus including an inflatable balloon and forma negative radial depression in a portion of the balloon. In someembodiments, as shown in FIGS. 77-83B, the balloon cover 2200 anddepression sleeve 2240 can be configured to form the radial depression334 in the distal end portion 332 of the balloon 318 (FIGS. 10 and 40 ).

However, in other embodiments, the balloon cover 2200 and depressionsleeve 2240 can be configured to form a negative radial depression in analternate or additional portion of the balloon (e.g., balloon 318). Forexample, the depression members 2256 can be included in an alternateportion of the depression sleeve 2240 and/or the first shell member 2202and the second shell member 2204 can be modified such that thedepression members 2256 of the depression sleeve 2240 surround analternate or additional portion of the balloon.

FIGS. 84-86 show another exemplary embodiment of a shell member 2302 fora balloon cover that is configured to receive a portion of a distal endportion of a delivery apparatus that includes an inflatable balloon anda positioning device mounted thereon and form a specified, final shapeof the balloon around the delivery apparatus. For example, in someembodiments, the balloon cover formed from two shell members 2302 andcan be configured to receive the distal end portion 309 of the deliveryapparatus 300, the balloon 318 mounted thereon, and the positioningdevice 1100 that is coupled to the distal end portion of the deliveryapparatus, proximal to the valve mounting portion 324. Further, in someembodiments, the balloon cover formed from the shell members 2302 can beconfigured to form the specified, final shape of the balloon mounted onthe distal end portion of the delivery apparatus (e.g., the radialdepression 334 of the distal end portion 332 of the balloon 318).

For example, a balloon cover that is similar to the balloon cover 2000(FIGS. 69-75C) can be formed by coupling (e.g., in mating engagement)two of the shell members 2302 with each other and holding the shellmembers 2302 together with the sleeve 2064 (e.g., as described abovewith reference to FIGS. 69-75C). For example, the shell member 2302shown in FIGS. 84-86 can be configured the same or similar to the firstshell member 2002 and/or the second shell member 2004 of the ballooncover 2000 (FIGS. 69-75C), except the shell member 2302 can include oneor more depression members 2256 formed in the first portion 2010 of theshell member 2302, as described further below.

As shown in the embodiment of FIGS. 84-86 , the shell member 2302includes one depression member 2256. Thus, a balloon cover formed bymating and coupling together two shell members 2302 would include twodepressions members 2256 (e.g., one in each shell member).

In other embodiments, the shell member 2302 can include more than onedepression member 2256 (e.g., two, three, or the like) and/or only oneof the two shell members 2302 forming the balloon cover can include oneor more depression members 2256 (and the other shell member may notinclude any depression members 2256).

The one or more depression members 2256 of the shell member 2302 can beconfigured to be moved into a radially inward configuration, in responseto an applied radially inward force, and as a result, form a negativeradial depression in one or more portions of the balloon received withinthe shell member 2302. The depression member(s) 2256 can function and beconfigured the same or similar to the depression members 2256 of theballoon cover 2200 (FIGS. 77-83B).

However, instead of being disposed in a depression sleeve (e.g.,depression sleeve 2240 of balloon cover 2200), the one or moredepression members 2256 can be disposed or formed within the shellmember 2302.

As shown in FIGS. 84-86 , the shell member 2302 comprises a firstportion 2310 and a second portion 2012. In some embodiments, the firstportion 2310 and the second portion 2012 can be continuous with oneanother. The second portion 2012 can be configured to receive apositioning device therein. Additionally, the second portion 2012 can beconfigured the same or similar to the second portion 2012 of the firstshell member 2002 and the second shell member 2004 of the balloon cover2000 (e.g., as shown in FIGS. 69-71 i), and thus, is labeled similarlyin FIGS. 84-86 .

The first portion 2310 can be configured similar to the first portion2010 of the first shell member 2002 and the second shell member 2004 ofthe balloon cover 2000 (e.g., as shown in FIGS. 69-71 i), except for theaddition of the depression member 2256.

Similar to the depression members described above with reference toFIGS. 78-81B, the depression member 2256 of the shell member 2302 canhave an attached end 2258 that is attached to and/or integral with(e.g., integrally formed with or molded as one part with) a remainder ofthe first portion 2010 (FIGS. 84-86 ). The depression member 2256 of theshell member 2302 can also have a free end 2260 that is unattached tothe remainder of the first portion 2010. In this way, the free end 2260of the depression member 2256 can freely move and can be configured tobend, flex, or deflect radially inward toward a central longitudinalaxis 2314 of the shell member 2302 (e.g., in response to inward pressureapplied to the free end 2260, as described herein).

The depression member 2256 can be an elongate member extending in theaxial direction from the attached end 2258 to the free end 2260, along aportion of the first length 2034 of the first portion 2310. In theembodiment of FIGS. 84-86 , the depression member 2256 is disposed inthe distal section 2028 of the depression 2026 (as described above withreference to FIG. 70 , the depression 2026 formed in the first portion2010 can include the distal section 2028, the proximal section 2030, andthe intermediate section 2032).

Though only a single depression member 2256 is shown in FIGS. 84-86 , inother embodiments, the shell member 2302 can include additionaldepression members 2256 disposed in a different portion of the firstportion 2310 (e.g., axially spaced away from the depression member 2256shown in FIGS. 84-86 ). In other embodiments, the single depressionmember 2256 of the shell member 2302 can be disposed at a differentaxial location along the depression (e.g., in the proximal section 2030or intermediate section 2032).

The depression member 2256 can be disposed within an opening 2306defined in the first portion 2310 of the shell member 2302 (FIGS. 84-86). For example, as shown in FIG. 86 , the opening 2306 can extend fromthe outer surface 2022 to and through the depression 2026. For example,side edges 2257 and the free end 2260 of the depression member 2256 canbe spaced away from (e.g., and non-contacting with) surfaces of thefirst portion 2310 that define the opening 2306 (FIGS. 84 and 85 ).

The outer surface 2270 of the depression member 2256 can be a relativelyplanar outer surface, except for the protrusion (e.g., bump) 2274disposed at or proximate to its free end 2260 (FIGS. 85 and 86 ). Forexample, as shown in FIG. 86 , the protrusion 2274 can extend radiallyoutward (away from the central longitudinal axis 2314) relative to aremainder of (e.g., the planar portion) of the outer surface 2270.Further, when the depression member 2256 is in the state orconfiguration shown in FIG. 86 (e.g., an unbiased, unflexed,undeflected, or relaxed state, as described above with reference to FIG.81A), the protrusion 2274 can extend radially outward relative to theouter surface 2022.

In some embodiments, the inner surface 2272 of the depression member2256 can be contoured along its axial length (FIG. 86 ). The innersurface 2272 can extend further radially inward (toward the centrallongitudinal axis 2314) along its axial length, from the attached end2258 to a location proximate to the free end 2260. For example, theinner surface 2272 can include the protrusion 2276 which extendsradially inward, toward the central longitudinal axis 2314, relative toa remainder of the inner surface 2272 (FIG. 86 ). The inner surface 2272can slope radially inward from the attached end 2258, to the protrusion2276. In this way, a thickness or width of the depression member 2256can be largest at the axial location of the protrusion 2276 (andprotrusion 2274, as shown in FIG. 86 ).

In some embodiments, the shape and/or contour of the inner surface 2272(and the protrusion 2276) can be configured based on a specified, finalshape of a portion of the balloon (e.g., balloon 318) which it isconfigured to cover and surround. For example, in some embodiments (asdescribed above), the inner surface 2272 can be shaped according to aspecified final shape or contour of the distal end portion 332 of theballoon 318 (e.g., which, as shown in FIG. 40 , includes the radialdepression 334 in the distal end portion 332 of the balloon 318).

Thus, the free end 2260 of the depression member 2256 can be configuredto move radially inward in response to an applied force (e.g., appliedby sleeve 2064 when covering the first portion 2010 of the shell member2302). As such, when two of the shell members 2302 are coupled togetheraround the distal end portion of the delivery apparatus (as describedabove), and the sleeve or another coupling element is arranged over andagainst the outer surfaces 2022 of the first portions 2310 of the shellmembers 2302, the depression members 2256 of each shell member 2302 canbe depressed radially inward, thereby pressing against the balloon(e.g., balloon 318) and forming a negative radial depression (e.g.,shaped according to the shape and contour of the protrusion 2276 andinner surface 2272) in the balloon.

Returning to the discussion of the delivery apparatus, as introducedabove with reference to FIGS. 9 and 14 , the intermediate shaft 306 ofthe delivery apparatus 300 can include the proximal end portion 310 thatextends proximally from a proximal end of the handle 302, to an adaptor(e.g., adaptor 312 of FIGS. 9, 14, and 15 or adaptor 402 of FIG. 23 ).In some embodiments, the adaptor can be bonded to the proximal endportion 310 of the intermediate shaft 306 (e.g., via applying anadhesive material to the adaptor and/or the proximal end of theintermediate shaft 306 and curing the adhesive material via UV light).After bonding the adaptor to the intermediate shaft 306, the two partscan be permanently fixed to one another (e.g., not reversibly orremovably coupled to each other). However, in some instances, this typeof connection or bonding between the adaptor and the intermediate shaft306 can result in leaks between the two parts and/or a weak connectionthat can degrade over time and/or during use.

Thus, in some embodiments, instead of bonding the intermediate shaft 306and the adaptor to each other, these components can be coupled to eachother via a shaft connector release assembly. The shaft connectorrelease assembly can be configured to provide a tight and leak-proofconnection between the intermediate shaft 306 and the adaptor. Further,the shaft connector release assembly can be configured to more quicklyand easily couple the intermediate shaft 306 and the adaptor to oneanother.

FIGS. 87A-96 show an exemplary embodiment of such a shaft connectorrelease assembly 2400 for the intermediate shaft 306 and an adaptor 2410(e.g., an adaptor similar to and/or that would take the place of theadaptor 312 in the delivery apparatus 300). The shaft connector releaseassembly 2400 can comprise a release sleeve 2402 and an adaptor insert2404.

FIGS. 87A and 87B show different views of the shaft connector releaseassembly 2400 in an assembled configuration and coupled to each of theintermediate shaft 306 and the adaptor 2410 (which, in some embodiments,can be the same as or similar to the adaptor 312). FIG. 88 is anexploded view that shows the shaft connector release assembly 2400 in adisassembled configuration and disassembled from the intermediate shaft306 and the adaptor 2410. FIGS. 89 and 90 show the shaft connectorrelease assembly 2400, alone, in an assembled configuration (FIG. 89 )and a disassembled configuration (FIG. 90 ). FIGS. 91-93 show differentviews of the release sleeve 2402 alone and FIGS. 94-96 show differentviews of the adaptor insert 2404 alone.

The shaft connector release assembly 2400 can have a centrallongitudinal axis 2408 (FIGS. 87-90 ). In some embodiments, when theshaft connector release assembly 2400 is coupled to the intermediateshaft 306 and the adaptor 2410, as shown in FIGS. 87A and 87B, thecentral longitudinal axis 2408 can be coaxial with the centrallongitudinal axis 320 of the delivery apparatus.

As shown in FIGS. 87A-88 , the release sleeve 2402 is configured toreceive and couple to and/or around a proximal end 307 (e.g., of theproximal end portion 310) of the intermediate shaft 306. For example,the release sleeve 2402 can be directly coupled to the proximal end 307of the intermediate shaft 306. As used herein, directly coupled canrefer to the coupling between two components without any interveningcomponents arranged therebetween.

The release sleeve 2402 is further configured to fit within and beremovably coupled to the adaptor insert 2404. In some embodiments, therelease sleeve 2402 and the adaptor insert 2404 can be directly coupledto one another.

Additionally, the adaptor insert 2404 can be configured to fit withinand coupled to a connecting portion 2412 of the adaptor 2410. In someembodiments, the adaptor insert can be directly coupled to/within theconnecting portion 2412.

In some embodiments, the connecting portion 2412 can also be referred toherein as an adaptor connecting portion 2412 and can either beintegrally formed with a remainder of the adaptor 2410 or configured tobe coupled to an adaptor, such as the adaptor 2410.

As shown in the perspective view of FIG. 87A and the cross-sectionalside view of FIG. 87B, when the shaft connector release assembly 2400 isassembled and connects the intermediate shaft 306 to the adaptor 2410,the connecting portion 2412 of the adaptor 2410 surrounds (e.g., isdisposed around) the adaptor insert 2404, the adaptor insert 2404surrounds the release sleeve 2402, and the release sleeve 2402 surroundsthe proximal end 307 of the intermediate shaft 306.

In some embodiments, the adaptor 2410 can comprise the connectingportion 2412 and a branch portion 2414. In other embodiments, theconnecting portion 2412 and the branch portion 2414 can be initiallyseparate from one another and then connected together (e.g., via weldingor other mechanical or chemical fixation means, as described furtherbelow).

In some embodiments, the branch portion 2414 can be similar to theadaptor 312 (FIGS. 9 and 14-16 ). For example, the branch portion 2414can include a first port 2416 configured to receive a guidewiretherethrough (e.g., similar to the first port 338 of adaptor 312) and asecond port 2418 configured to receive fluid (e.g., inflation fluid)from a fluid source (e.g., similar to the second port 340 of adaptor312). The second port 2418 can be fluidly coupled to an inner lumen ofthe intermediate shaft 306, as described above.

In some embodiments, the branch portion 2414 can be configured similarlyto the adaptor 402 of FIGS. 23-27 with the second port 2418 beingrotatable relative to a body of the branch portion 2414.

As shown in FIGS. 87A-88 , in some embodiments, the connecting portion2412 of the adaptor 2410 can have a larger outer diameter than thebranch portion 2414 and the intermediate shaft 306.

As shown in FIG. 88 , the connecting portion 2412 can include a cavity2420 that is configured (e.g., shaped) to receive the adaptor insert2404 therein. For example, as described in further detail below, in someembodiments, the cavity 2420 and an outer surface of the adaptor insert2404 can be correspondingly shaped such that the adaptor insert 2404 andthe connecting portion 2412 can be press fit together (e.g., in matingengagement).

Turning to FIGS. 91-93 , a perspective, side, and cross-sectional view,respectively, of the release sleeve 2402 is shown. The release sleeve2402 can comprise a first (e.g., distal) portion 2422 and a second(e.g., proximal) portion 2424.

The first portion 2422 can comprise a first flange 2426 disposed at afirst (e.g., distal) end 2428 of the release sleeve 2402. In someembodiments, the first portion 2422 can comprise one or more additionalflanges, extension portions, or ring portions that extend radiallyoutward from a body 2434 of the first portion 2422, around acircumference of the release sleeve 2402 (as such, they can also bereferred to as outwardly extending ring portions).

In some embodiments, as shown in FIGS. 91-93 , the release sleeve 2402can include two additional flanges, including a second flange 2430 and athird flange 2432 which are spaced apart from one another in the axialdirection (and are also spaced apart from the first flange 2426). Inother embodiments, the release sleeve 2402 can include more or less thantwo additional flanges (e.g., zero, one, three, four, or the like).

The second portion 2424 can be configured to flex or bend radiallyinward, relative to the central longitudinal axis 2408 (which can alsobe a central longitudinal axis of the release sleeve 2402 when includedin the shaft connector release assembly 2400, as shown in FIGS. 89 and90 ).

As shown in FIGS. 91-93 , the second portion 2424 can comprise a body2436 that narrows from the first portion 2422 to a wider, collar portion2438 disposed at a second (e.g., proximal) end 2440 of the releasesleeve 2402. The second portion 2424 can also be referred to as aflexible portion of the release sleeve 2402.

The collar portion 2438 can extend radially outward from a narrowerportion of the body 2436. For example, as shown in FIG. 93 , at thesecond end 2440, the collar portion 2438 can have a first diameter 2442which is larger than a second diameter 2444 of the narrow portion of thebody 2436. The first diameter 2442 can also be larger than a thirddiameter 2446 of a wider portion of the body 2436 which is disposedadjacent to the first portion 2422 (e.g., when the release sleeve 2402is disassembled from the adaptor insert 2404, as shown in FIGS. 90-93 ).

The second portion 2424 can also include one or more slots 2448 thatextend axially through the body 2436 and the collar portion 2438, to thesecond end 2440. The one or more slots 2448 can be configured to provideflexibility to the second portion 2424 such that the collar portion 2438can flex radially inward, toward the central longitudinal axis 2408 inresponse to a radially inward pressure from the adaptor insert 2404(e.g., when arranged within the adaptor insert 2404 in the shaftconnector release assembly 2400, as described further below). In someembodiments, the second portion 2424 can include a plurality of slots2448 that are spaced apart from one another around a circumference ofthe body 2436.

In some embodiments, the release sleeve 2402 can include an inner lumen2450 with an inner diameter 2552 that is relatively constant along itslength, from the first end 2428 to the second end 2440 whendisassembled, as shown in FIG. 93 . However, as described above andfurther below, the collar portion 2438 can be pushed or depressedradially inward, thereby narrowing the inner lumen 2450 at the secondend 2440 of the release sleeve 2402.

Turning to FIGS. 94-96 , a perspective, side, and cross-sectional view,respectively, of the adaptor insert 2404 is shown. The adaptor insert2404 can comprise a body 2454 which extends from a first (e.g., distal)end 2456 to a second (e.g., proximal) end 2458 of the adaptor insert2404.

In some embodiments, at the first end 2456, an outer surface 2460 of thebody 2454 can have a wider, flanged portion 2462 with a first outerdiameter 2464. The flanged portion 2462 can be configured (e.g., sized)to fit within a wider cavity portion 2421 of the cavity 2420 of theconnecting portion 2412 of the adaptor 2410 (FIGS. 87A-88 )

In some embodiments, at the second end 2458, the body 2454 can have anarrower portion 2466 and the outer surface 2460 at the narrower portion2466 can have a second outer diameter 2465. In some embodiments, thesecond outer diameter 2465 can vary along the axial length of thenarrower portion 2466 (as shown in FIG. 96 ). However, in otherembodiments, the second outer diameter 2465 can be constant along theaxial length of the narrower portion 2466.

In some embodiments, the outer surface 2460 of the body 2454 can haveone or more additional geometric features, such as a ring portion 2468.In other embodiments, the body 2454 may not include the ring portion2468.

The body 2454 of the adaptor insert 2404 can include an inner surface(or lumen) 2470 with a diameter that varies along the axial length ofthe adaptor insert 2404 and defines an interior cavity 2471 that cancomprise a plurality of cavity portions with varying diameters (FIG. 96).

In some embodiments, the cavity portions defined by the inner surface2470 include a first cavity portion 2472 with a first inner diameter2474. The first cavity portion 2472 can be configured to receive thefirst flange 2426 therein (FIGS. 87B and 89 ).

In some embodiments, the cavity portions defined by the inner surface2470 include a second cavity portion 2476 with a second inner diameter2478 (FIG. 96 ). In some embodiments, the second cavity portion 2476 caninclude a tapered portion 2480 that narrows (in diameter) to a thirdcavity portion 2482 having a third inner diameter 2484. Thus, the thirdinner diameter 2484 can be smaller than the second inner diameter 2478(FIG. 96 ).

In some embodiments, the cavity portions defined by the inner surface2470 can include a fourth cavity portion 2486 that is configured toreceive the sealing member 2406 therein (FIGS. 96 and 87B). The fourthcavity portion 2486 can have a fourth inner diameter 2488 that is largerthan the third inner diameter 2484.

In some embodiments, the cavity portions defined by the inner surface2470 can include a fifth cavity portion 2490 which is part of thenarrower portion 2466 and has a fifth inner diameter 2492. In someembodiments, as shown in FIG. 96 , the fifth inner diameter 2492 issmaller than the third inner diameter 2484.

As shown in FIG. 87B, a majority of the second portion 2424 of therelease sleeve 2402 can be configured to fit and be received within thethird cavity portion 2482 of the adaptor insert 2404. Further, amajority of the first portion 2422 of the release sleeve 2402 can beconfigured to fit and be received within the second cavity portion 2476of the adaptor insert 2404. In some embodiments, as shown in FIG. 87Band introduced above, the first flange 2426 of the release sleeve 2402can be configured to fit and be received within the first cavity portion2472 of the adaptor insert 2404.

For example, during insertion of the release sleeve 2402 into theadaptor insert 2404, the collar portion 2438 of the second portion 2424of the release sleeve 2402 can begin to depress radially inward is itcomes into contact with (and slides against) the inner surface 2470 inthe tapered portion 2480 of the second cavity portion 2476. For example,the first diameter 2442 of the collar portion 2438 (when disassembledfrom the adaptor insert, as shown in FIG. 93 ) can be larger than thethird inner diameter 2484 of the third cavity portion 2482. Thus, whenthe collar portion 2438 is arranged within the third cavity portion 2482of the adaptor insert 2404, as shown in FIG. 87B, the collar portion2438 of the release sleeve 2402 is depressed radially inward and, whendisposed around the intermediate shaft 306 (as shown in FIG. 87B), canpress against the intermediate shaft 306. As a result, the releasesleeve 2402 can couple tightly to and around the intermediate shaft 306.For example, the release sleeve 2402 can be held in coupling contactwith the proximal end 307 of the intermediate shaft 306 via radiallyinward pressure from the adaptor insert 2404.

For example, in some embodiments, when the release sleeve 2402 isreceived within the interior cavity 2471 of the adaptor insert 2404 andthe collar portion 2438 is arranged within the third cavity portion2482, the first diameter 2442 of the collar portion 2438 can be smalleror equal to the third inner dimeter 2484 of the third cavity portion2482.

Further, in some embodiments, as shown in FIG. 87B, the sealing member2406 can be positioned within the fourth cavity 2486 of the adaptorinsert and adjacent to the collar portion 2438. As a result, the sealingmember 2406 can encircle and seal around the intermediate shaft 306 andreduce a likelihood of fluid passing through the adaptor 2410 and to theinner lumen of the intermediate shaft 306 from escaping via the adaptor2410. As such, the shaft connector release assembly 2400 is configuredto provide a secure and fluid-tight connection between the intermediateshaft 306 and the adaptor 2410 (or a similar adaptor, such as one of theother adaptors described herein)

The components of the shaft connector release assembly 2400 (e.g., asshown in the exploded view of FIG. 90 ) can be assembled together and tothe adaptor 2410 (or a similar adaptor) and/or the intermediate shaft306 in various manners to form the final, assembled shaft connectorrelease assembly 2400 which connects the intermediate shaft 306 and theadaptor 2410 to one another (as shown in FIGS. 87A, 87B, and 89 ).

In some embodiments, to assemble the shaft connector release assembly2400 to the intermediate shaft 306 and the adaptor 2410, the releasesleeve 2402 can be positioned around the proximal end 307 of theintermediate shaft 306 (or another shaft to be coupled to a connector).In some embodiments, the sealing member 2406 can be arranged within theadaptor insert (e.g., in the fourth cavity 2486). Together, the releasesleeve 2402 and the intermediate shaft 306 can be slid into the adaptorinsert (as described above). In some embodiments, the release sleeve2402 and the adaptor insert 2404 can be sized such that they can besecurely press fit together in coupling engagement with one another andto the intermediate shaft.

In some embodiments, the assembled shaft connector release assembly 2400can be configured to be press fit into the connecting portion 2412 ofthe adaptor 2410. For example, as described above, the adaptor insert2404 can be shaped to fit tightly within and couple securely to theconnecting portion 2412 (as shown in FIG. 87B). As a result, the shaftconnector release assembly 2400 can be securely coupled to the adaptor2410, thereby coupling the intermediate shaft 306 to the adaptor 2410.

In other embodiments, the adaptor 2410 (or other adaptor) can bemanufactured as two parts. For example, the connecting portion 2412 canbe separate from a remainder of the adaptor 2410 (e.g., the branchportion 2414). In such embodiments, the assembled shaft connectorrelease assembly 2400 (assembled around the intermediate shaft 306) canbe press fit into the connecting portion 2412 or the assembled shaftconnector release assembly 2400 can be welded (e.g., via sonic welding)to and within the connecting portion 2412. In either case, theconnecting portion 2412, coupled to the assembled shaft connectorrelease assembly 2400, can then be permanently fixed or welded (e.g.,via sonic welding) to the branch portion 2414 of the adaptor 2410.

In some embodiments, when the connecting portion 2412 is manufactured asa separate piece from the adaptor, the adaptor could be one of the otheradaptors described herein (e.g., adaptor 312 shown in FIGS. 14 and 15 oradaptor 402 shown in FIGS. 23-27 ) and then the connecting portion 2412can be welded to the adaptor, as described above.

In still other embodiments, the adaptor insert 2404 and the adaptor 2410can be formed as one piece. For example, the adaptor insert 2404 and theadaptor 2410 can be molded together (e.g., via overmolding). In suchembodiments, the release sleeve 2402, coupled around the intermediateshaft 306, can then be insert into the adaptor insert 2404 (as describedabove). As a result, the intermediate shaft 306 and the adaptor 2410would be coupled securely together.

In some embodiments, the rotatable knob 314 shown in FIGS. 15-22 can beattached the intermediate shaft 306 (as described above), distal to theconnecting portion 2412 of the adaptor (e.g., the adaptor 2410 and theshaft connector release assembly 2400 can replace the adaptor 312 shownin FIGS. 15-17 ).

Additional Examples of the Disclosed Technology

In view of the above described implementations of the disclosed subjectmatter, this application discloses the additional examples enumeratedbelow. It should be noted that one feature of an example in isolation ormore than one feature of the example taken in combination and,optionally, in combination with one or more features of one or morefurther examples are further examples also falling within the disclosureof this application.

Example 1. A delivery apparatus comprising a first shaft that isconfigured to rotate around a central longitudinal axis of the deliveryapparatus to rotationally align a prosthetic valve mounted on thedelivery apparatus with native anatomy at a target implantation site; asecond shaft extending through the first shaft and having a distal endportion extending distally beyond a distal end portion of the firstshaft; an inflatable balloon coupled to the distal end portion of thefirst shaft; and a shoulder arranged within the balloon and a radiopaquemarker mounted on or embedded within the shoulder at a location spacedradially outward from an outer surface of the distal end portion of thesecond shaft, wherein the marker is reflection asymmetric along an axisthat is parallel to the central longitudinal axis, and wherein theshoulder is configured such that when the prosthetic valve is mounted onthe balloon in a radially compressed state, the shoulder resistsmovement of the prosthetic valve relative to the balloon in an axialdirection.

Example 2. The delivery apparatus of any example herein, particularlyexample 1, wherein the shoulder comprises a polymeric body and themarker is mounted on or embedded within the polymeric body.

Example 3. The delivery apparatus of any example herein, particularlyeither example 1 or 2, wherein the shoulder is a distal shoulderarranged within a distal end portion of the balloon and mounted on thedistal end portion of the second shaft.

Example 4. The delivery apparatus of any example herein, particularlyexample 3, wherein the distal shoulder is arranged proximal and adjacentto a nose cone of the delivery apparatus, the nose cone mounted to thedistal end portion of the second shaft.

Example 5. The delivery apparatus of any example herein, particularlyexample 3 or example 4, wherein the distal shoulder comprises a baseportion and a flared portion, the flared portion extending radiallyoutward from the base portion, toward a valve mounting portion of thedelivery apparatus, the valve mounting portion configured to receive theprosthetic valve in a radially compressed state, and wherein the markeris arranged on or embedded within the flared portion.

Example 6. The delivery apparatus of any example herein, particularlyexample 5, wherein the flared portion includes a plurality of wingsflaring radially outward from the base portion, in a proximal directionand at an angle relative to the central longitudinal axis, and whereinthe marker is arranged on or embedded within one of the plurality ofwings.

Example 7. The delivery apparatus of any example herein, particularlyany one of examples 3-6, wherein the marker is positioned at a proximalend of the distal shoulder, the proximal end arranged adjacent to avalve mounting portion of the delivery apparatus, the valve mountingportion configured to receive the prosthetic valve in the radiallycompressed state, and wherein the balloon overlays the valve mountingportion.

Example 8. The delivery apparatus of any example herein, particularlyany one of examples 1-7, wherein a proximal end portion of the balloonis coupled to the distal end portion of the first shaft and a distal endportion of the balloon is coupled to a nose cone coupled to the distalend portion of the second shaft.

Example 9. The delivery apparatus of any example herein, particularlyexample 1 or example 2, wherein the shoulder is a proximal shoulderarranged within a proximal end portion of the balloon, the proximalshoulder arranged proximal to a valve mounting portion of the deliveryapparatus.

Example 10. The delivery apparatus of any example herein, particularlyany one of examples 1-9, wherein the marker is shaped as a letter of analphabet.

Example 11. The delivery apparatus of any example herein, particularlyany one of examples 1-10, wherein the marker comprises tantalum.

Example 12. The delivery apparatus of any example herein, particularlyany one of examples 1-11, wherein the marker comprises aplatinum-iridium alloy.

Example 13. The delivery apparatus of any example herein, particularlyexample 12, wherein an alloy proportion of the platinum-iridium alloy is90:10.

Example 14. The delivery apparatus of any example herein, particularlyany one of examples 1-13, wherein the delivery apparatus furtherincludes a nose cone coupled to the distal end portion of the secondshaft and wherein the nose cone is arranged distal to the shoulder.

Example 15. The delivery apparatus of any example herein, particularlyany one of examples 1-14, wherein the first shaft is arranged within andconfigured to rotate relative to a third shaft of the deliveryapparatus, wherein the distal end portion of the first shaft extendsdistally beyond a distal end of the third shaft, and further comprisinga handle portion including a steering mechanism configured toselectively adjust a curvature of the third shaft.

Example 16. The delivery apparatus of any example herein, particularlyany one of examples 1-15, wherein the first shaft comprises a firstlayer of braided material and a second layer of braided materialembedded therein, wherein the first layer of braided material extendsalong an entire length of the first shaft, from a proximal end to adistal end of the first shaft, and the second layer of braided materialextends a majority of the entire length of the first shaft, from theproximal end to a distance spaced away from the distal end.

Example 17. The delivery apparatus of any example herein, particularlyany one of examples 1-16, further comprising a handle portion andwherein the first shaft extends distally from the handle portion and hasa proximal end portion that extends proximally from the handle portionto an adaptor, the adaptor including a body coupled to the proximal endportion, a first port extending axially from the body, relative to thecentral longitudinal axis, and a second port extending at an angle fromthe body, relative to the central longitudinal axis.

Example 18. The delivery apparatus of any example herein, particularlyexample 17, wherein an inner lumen of the second port is fluidly coupledto an annular space defined between an inner surface of the first shaftand an outer surface of the second shaft and a fluid passageway formedbetween the outer surface of the distal end portion of the second shaftand an inner surface of the balloon.

Example 19. The delivery apparatus of any example herein, particularlyexample 17 or example 18, wherein the second port is configured torotate around the central longitudinal axis and relative to the body andthe first port of the adaptor.

Example 20. The delivery apparatus of any example herein, particularlyany one of examples 17-19, further comprising a knob mounted on theproximal end portion of the first shaft, the knob configured to rotatethe first shaft.

Example 21. The delivery apparatus of any example herein, particularlyexample 20, wherein the knob comprises an outer housing and an anchorarranged within the outer housing, wherein the anchor is configured tocouple the knob to the proximal end portion of the first shaft.

Example 22. The delivery apparatus of any example herein, particularlyexample 21, wherein the outer housing includes two or more housingportions that are configured to be removably coupled to one another andcouple together around the anchor.

Example 23. The delivery apparatus of any example herein, particularlyexample 21 or example 22, wherein the anchor includes an aligning tabconfigured to align the adaptor relative to the marker of the shoulder.

Example 24. The delivery apparatus of any example herein, particularlyexample 23, wherein the anchor includes a shaft portion defining aninner lumen configured to receive and couple around the proximal endportion of the first shaft and wherein the aligning tab extends radiallyoutward from the shaft portion.

Example 25. The delivery apparatus of any example herein, particularlyexample 24, wherein the shaft portion of the anchor includes one or morecentering ribs spaced apart around a circumference of the inner lumenand extending along the inner lumen.

Example 26. The delivery apparatus of any example herein, particularlyany one of examples 22-25, wherein the outer housing comprises aninternal cavity configured to receive the adaptor and wherein the two ormore housing portions are configured to be removably coupled to oneanother and couple together around the adaptor.

Example 27. The delivery apparatus of any example herein, particularlyexample 26, wherein the knob further comprises a cap configured to becoupled to a proximal end of the outer housing such that the two or morehousing portions are held together.

Example 28. The delivery apparatus of any example herein, particularlyexample 27, wherein a proximal end of the first port of the adaptorextends outward in a proximal direction from the cap.

Example 29. The delivery apparatus of any example herein, particularlyany one of examples 22-28, wherein the outer housing comprises one ormore indicators that indicate to a user which way the knob should berotated in order to align the radiopaque marker with a guidewire runningthrough a center of the delivery apparatus.

Example 30. The delivery apparatus of any example herein, particularlyexample 29, where each indicator comprises a printed marking including aline representing the guidewire, a visual of the radiopaque marker oneither side of the line, and an arrow on either side of the lineindicating to the user which way to rotate the knob if the radiopaquemarker does not appear aligned with the guidewire under fluoroscopyduring an implantation procedure with the delivery apparatus.

Example 31. The delivery apparatus of any example herein, particularlyany one of examples 1-30, wherein the balloon includes a plurality ofoverlapping pleats wrapped around the second shaft.

Example 32. The delivery apparatus of any example herein, particularlyany one of examples 1-31, further comprising a third shaft surroundingthe first shaft, wherein the first shaft is configured to rotate withinthe third shaft and the first shaft and third shaft are configured totranslate axially relative to one another, and wherein the third shaftincludes a distal tip portion including a plurality of internal helicalexpansion grooves and a plurality of external helical expansion groovesthat are configured to allow the distal tip portion to flex radiallyoutward.

Example 33. The delivery apparatus of any example herein, particularlyexample 32, wherein the distal tip portion comprises a coupling portionmounted around a distal end of the first shaft and a flex portionextending distally outward from the coupling portion and wherein theplurality of internal helical expansion grooves are arranged in an innersurface of the flex portion and curve around the central longitudinalaxis, from a proximal end of the flex portion to a distal end of thedistal tip portion.

Example 34. The delivery apparatus of any example herein, particularlyexample 33, wherein the distal tip portion is axially movable from afirst position where the distal tip portion is arranged away from andoff the balloon and the distal end portion of the first shaft extendsdistally past the distal end of the distal tip portion to a secondposition wherein the distal tip portion is arranged over a proximal endportion of the balloon and a distal end portion of the third shaftsurrounds the distal end portion of the first shaft, and wherein theplurality of internal helical expansion grooves are configured to reduceengagement between pleats of the balloon and the plurality of internalhelical expansion grooves when the balloon is rotated with rotation ofthe first shaft when the distal tip portion is in the second position.

Example 35. The delivery apparatus of any example herein, particularlyexample 34, wherein the shoulder is a distal shoulder arranged within adistal end portion of the balloon and mounted on the distal end portionof the second shaft and wherein, when the distal tip portion is in thefirst position, a distal end portion of the balloon includes a radialdepression that is depressed inward, toward the central longitudinalaxis, relative to an outermost radial surface of the distal shoulder.

Example 36. The delivery apparatus of any example herein, particularlyexample 35, wherein the radial depression of the distal end portion ofthe balloon is configured to radially expand when the distal tip portionis moved from the first position to the second position.

Example 37. A delivery apparatus, comprising: a first shaft configuredto rotate around a central longitudinal axis of the delivery apparatusto rotationally align a prosthetic valve mounted on the deliveryapparatus with native anatomy at a target implantation site; a secondshaft extending through the first shaft and having a distal end portionextending distally beyond a distal end portion of the first shaft; aninflatable balloon coupled to the distal end portion of the first shaft;and a polymeric body mounted on the distal end portion of the secondshaft and a radiopaque marker mounted on or embedded within thepolymeric body.

Example 38. The delivery apparatus of any example herein, particularlyexample 37, wherein the polymeric body is a distal shoulder arrangedwithin a distal end portion of the balloon and mounted on the distal endportion of the second shaft.

Example 39. The delivery apparatus of any example herein, particularlyexample 37 or example 33, wherein the distal shoulder is arrangedproximal and adjacent to a nose cone of the delivery apparatus, the nosecone mounted to the distal end portion of the second shaft and whereinthe distal shoulder is configured such that when the prosthetic valve ismounted on the balloon in a radially compressed state, the distalshoulder resists movement of the prosthetic valve relative to theballoon in an axial direction.

Example 40. The delivery apparatus of any example herein, particularlyany one of examples 37-39, wherein the distal shoulder comprises a baseportion and a flared portion, the flared portion extending radiallyoutward from the base portion, toward a valve mounting portion of thedelivery apparatus, the valve mounting portion configured to receive theprosthetic valve in a radially compressed state, and wherein the markeris arranged on or embedded within the flared portion.

Example 41. The delivery apparatus of any example herein, particularlyexample 40, wherein the flared portion includes a plurality of wingsflaring radially outward from the base portion, in a proximal directionand at an angle relative to the central longitudinal axis, and spacedapart from one another around a circumference of the flared portion, andwherein the marker is centered on one of the plurality of wings suchthat the marker is centered along the central longitudinal axis.

Example 42. The delivery apparatus of any example herein, particularlyexample 37, wherein the polymeric body is a nose cone mounted on thedistal end portion of the delivery apparatus and wherein the nose coneis arranged distal to a valve mounting portion of the deliveryapparatus, the valve mounting portion configured to receive theprosthetic valve in a radially compressed state and wherein the balloonoverlays the valve mounting portion.

Example 43. The delivery apparatus of any example herein, particularlyexample 37, wherein the polymeric body is a proximal shoulder arrangedwithin a proximal end portion of the balloon, the proximal shoulderarranged proximal to a valve mounting portion of the delivery apparatus,the valve mounting portion configured to receive the prosthetic valve ina radially compressed state.

Example 44. The delivery apparatus of any example herein, particularlyany one of examples 37-43, wherein the polymeric body is not radiopaque.

Example 45. The delivery apparatus of any example herein, particularlyany one of examples 37-44, wherein the marker is reflection asymmetricalong an axis that is parallel to the central longitudinal axis.

Example 46. The delivery apparatus of any example herein, particularlyexample 45, wherein the marker is shaped as a letter of an alphabet.

Example 47. The delivery apparatus of any example herein, particularlyany one of examples 37-46, wherein the marker comprises tantalum.

Example 48. The delivery apparatus of any example herein, particularlyany one of examples 37-47, wherein the marker comprises aplatinum-iridium alloy.

Example 49. The delivery apparatus of any example herein, particularlyany one of examples 37-48, wherein the second shaft includes an innerlumen configured to receive a guidewire and wherein an annular space isdefined between an outer surface of the second shaft and an innersurface of the first shaft, the annular spaced configured to receive aninflation fluid and fluidly coupled to a fluid passageway formed betweenthe outer surface of the distal end portion of the second shaft and aninner surface of the balloon.

Example 50. The delivery apparatus of any example herein, particularlyany one of examples 37-49, wherein the first shaft comprises a firstlayer of braided material and a second layer of braided materialembedded therein, wherein the first layer of braided material extendsalong an entire length of the first shaft, from a proximal end to adistal end of the first shaft, and the second layer of braided materialextends a majority of the entire length of the first shaft, from theproximal end to a distance spaced away from the distal end.

Example 51. The delivery apparatus of any example herein, particularlyany one of examples 37-50, wherein the first shaft is arranged withinand configured to rotate relative to a third shaft of the deliveryapparatus and further comprising a handle portion including a steeringmechanism configured to selectively adjust a curvature of the thirdshaft.

Example 52. The delivery apparatus of any example herein, particularlyany one of examples 37-51, further comprising a handle including one ormore adjustment mechanisms configured to adjust operation of thedelivery apparatus, wherein the first shaft extends distally from thehandle to the distal end portion of the first shaft, wherein the firstshaft has a proximal end portion that extends proximally from the handleto an adaptor, and further comprising a rotatable knob mounted on theproximal end portion of the first shaft, the knob configured to rotatethe first shaft.

Example 53. The delivery apparatus of any example herein, particularlyexample 52, wherein the adaptor comprises a body coupled to the proximalend portion, a first port extending axially from the body, relative tothe central longitudinal axis, and a second port extending at an anglefrom the body, relative to the central longitudinal axis, wherein thefirst port is coupled to an inner lumen of the second shaft andconfigured to receive a guidewire, and wherein the second port isfluidly coupled to an annular space defined between an outer surface ofthe second shaft and an inner surface of the first shaft, the annularspaced fluidly coupled to a fluid passageway formed between the outersurface of the distal end portion of the second shaft and an innersurface of the balloon.

Example 54. The delivery apparatus of any example herein, particularlyexample 53, wherein the second port is configured to rotate around thecentral longitudinal axis and relative to the body and the first port ofthe adaptor.

Example 55. The delivery apparatus of any example herein, particularlyany one of examples 52-54, wherein the knob comprises an outer housingand an anchor arranged within the outer housing, wherein the anchor isconfigured to couple the knob to the proximal end portion of the firstshaft.

Example 56. The delivery apparatus of any example herein, particularlyexample 55, wherein the outer housing includes two or more housingportions that are configured to be removably coupled to one another andcouple together around the anchor and around the adaptor such that theanchor and the adaptor are enclosed within the outer housing.

Example 57. The delivery apparatus of any example herein, particularlyexample 56, wherein the knob further comprises a cap configured to becoupled to a proximal end of the outer housing such that the two or morehousing portions are held together.

Example 58. The delivery apparatus of any example herein, particularlyany one of examples 55-57, wherein the outer housing comprises one ormore indicators that indicate to a user which way the knob should berotated in order to align the radiopaque marker with a guidewire runningthrough a center of the delivery apparatus.

Example 59. The delivery apparatus of any example herein, particularlyexample 58, where each indicator comprises a printed marking including aline representing the guidewire, a visual of the radiopaque marker oneither side of the line, and an arrow on either side of the lineindicating to the user which way to rotate the knob if the radiopaquemarker does not appear aligned with the guidewire under fluoroscopyduring an implantation procedure with the delivery apparatus.

Example 60. The delivery apparatus of any example herein, particularlyexample 55 or example 56, wherein the anchor includes an aligning tabconfigured to circumferentially align the adaptor relative to the markerof the polymeric body.

Example 61. The delivery apparatus of any example herein, particularlyexample 60, wherein the anchor includes a shaft portion defining aninner lumen configured to receive and couple around the proximal endportion of the first shaft and wherein the aligning tab extends radiallyoutward from the shaft portion.

Example 62. The delivery apparatus of any example herein, particularlyexample 61, wherein the shaft portion of the anchor includes one or morecentering ribs spaced apart around a circumference of the inner lumenand extending along the inner lumen and an aperture extending between anouter surface and an inner surface of the shaft portion and arranged ina central portion of the shaft portion.

Example 63. The delivery apparatus of any example herein, particularlyany one of examples 37-62, wherein the balloon includes a plurality ofoverlapping pleats wrapped around the second shaft and overlaying avalve mounting portion of the delivery apparatus, the valve mountingportion configured to receive the prosthetic valve in a radiallycompressed state.

Example 64. The delivery apparatus of any example herein, particularlyany one of examples 37-63, further comprising a third shaft surroundingthe first shaft, wherein the first shaft is configured to rotate withinthe third shaft and the first shaft and third shaft are configured totranslate axially relative to one another, and wherein the third shaftincludes a distal tip portion including a plurality of helical expansiongrooves arranged in an inner surface of the distal tip portion andconfigured to allow the distal tip portion to flex radially outward.

Example 65. The delivery apparatus of any example herein, particularlyexample 64, wherein the distal tip portion is axially movable from afirst position where the distal tip portion is arranged away from andoff the balloon and the distal end portion of the first shaft extendsdistally past a distal end of the distal tip portion to a secondposition where the distal tip portion is arranged over a proximal endportion of the balloon and a distal end portion of the third shaftsurrounds the distal end portion of the first shaft, and wherein theplurality of helical expansion grooves are configured to reduceengagement between pleats of the balloon and the plurality of helicalexpansion grooves when the balloon is rotated with rotation of the firstshaft when the distal tip portion is in the second position.

Example 66. The delivery apparatus of any example herein, particularlyexample 65, further comprising a distal shoulder arranged within adistal end portion of the balloon and mounted on the distal end portionof the second shaft and wherein, when the distal tip portion is in thefirst position, the distal end portion of the balloon includes a radialdepression that is depressed inward, toward the central longitudinalaxis, relative to an outermost radial surface of the distal shoulder.

Example 67. The delivery apparatus of any example herein, particularlyexample 66, wherein the radial depression of the distal end portion ofthe balloon is configured to radially expand when the distal tip portionis moved from the first position to the second position.

Example 68. A medical assembly for replacing a native valve of a heart,comprising: a delivery apparatus, the delivery apparatus comprising: afirst shaft configured to rotate around a central longitudinal axis ofthe delivery apparatus; a second shaft extending through the first shaftand having a distal end portion extending distally beyond a distal endportion of the first shaft; an inflatable balloon coupled to the distalend portion of the first shaft; and a radiopaque marker arranged on adistal end portion of the delivery apparatus. The medical assemblyfurther comprising a prosthetic heart valve mounted in a radiallycompressed configuration onto and around the balloon, wherein the markeris offset, in a circumferential direction relative to the centrallongitudinal axis, from a location of a selected commissure of theprosthetic heart valve, wherein the first shaft is configured to rotateto rotationally align the marker at the native valve such that, afterinflating the balloon to radially expand the prosthetic heart valve, theprosthetic heart valve is implanted with the selected commissure of theprosthetic heart valve circumferentially aligned with a targetcommissure of the native valve.

Example 69. The medical assembly of any example herein, particularlyexample 68, wherein the radiopaque marker is reflection asymmetric alongan axis that is parallel to a central longitudinal axis of the deliveryapparatus.

Example 70. The medical assembly of any example herein, particularlyexample 68 or example 69, wherein the marker is mounted on or embeddedwithin a polymeric body mounted on the distal end portion of the secondshaft.

Example 71. The medical assembly of any example herein, particularlyexample 70, wherein the marker is mounted on or embedded within thepolymeric body at a location spaced radially outward from an outersurface of the distal end portion of the second shaft.

Example 72. The medical assembly of any example herein, particularlyexample 70 or example 71, wherein the polymeric body is a distalshoulder arranged inside the balloon, distal to the prosthetic heartvalve.

Example 73. The medical assembly of any example herein, particularlyexample 70 or example 71, wherein the polymeric body is a proximalshoulder arranged inside balloon, proximal to the prosthetic heartvalve.

Example 74. The medical assembly of any example herein, particularlyexample 70 or example 71, wherein the polymeric body is a nose cone, thenose cone coupled to the distal end portion of the second shaft, distalto the prosthetic heart valve.

Example 75. The medical assembly of any example herein, particularly anyone of examples 68-74, wherein the balloon is pleated and radiallywrapped around the second shaft, underneath the radially compressedprosthetic heart valve.

Example 76. The medical assembly of any example herein, particularly anyone of examples 68-75, further comprising a guidewire extending thoughthe second shaft and through a center of the distal end portion of thedelivery apparatus.

Example 77. The medical assembly of any example herein, particularly anyone of examples 68-76, wherein the marker is configured to indicate alocation of the selected commissure of the prosthetic heart valve afterradially expanding the prosthetic heart valve via inflating the balloon.

Example 78. The medical assembly of any example herein, particularly anyone of examples 68-77, wherein the first shaft comprises two layers of abraided material embedded therein, wherein a first layer of the twolayers of the braided material extends along an entire length of thefirst shaft and a second layer of the two layers of the braided materialis shorter than the first layer.

Example 79. The medical assembly of any example herein, particularly anyone of examples 68-78, wherein the delivery apparatus further comprisesa third shaft and a steering mechanism configured to selectively adjusta curvature of the third shaft and wherein the first shaft is configuredto rotate within the third shaft.

Example 80. The medical assembly of any example herein, particularly anyone of examples 68-79, further comprising a handle including one or moreadjustment mechanisms configured to adjust operation of the deliveryapparatus, wherein the first shaft extends distally from the handle tothe distal end portion of the first shaft, wherein the first shaft has aproximal end portion that extends proximally from the handle, andfurther comprising a rotatable knob mounted on the proximal end portionof the first shaft, the knob configured to rotate the first shaft.

Example 81. The medical assembly of any example herein, particularlyexample 80, further comprising an adaptor mounted to the proximal endportion of the first shaft, wherein the adaptor comprises a body coupledto the proximal end portion, a first port extending axially from thebody, relative to the central longitudinal axis, and a second portextending at an angle from the body, relative to the centrallongitudinal axis, wherein the first port is coupled to an inner lumenof the second shaft and configured to receive a guidewire, and whereinthe second port is fluidly coupled to an annular space defined betweenan outer surface of the second shaft and an inner surface of the firstshaft, the annular spaced fluidly coupled to a fluid passageway formedbetween the outer surface of the distal end portion of the second shaftand an inner surface of the balloon.

Example 82. The medical assembly of any example herein, particularlyexample 81, wherein the second port is configured to rotate around thecentral longitudinal axis and relative to the body and the first port ofthe adaptor.

Example 83. The medical assembly of any example herein, particularly anyone of examples 81-82, wherein the knob comprises an outer housing andan anchor arranged within the outer housing, wherein the anchor isconfigured to couple the knob to the proximal end portion of the firstshaft.

Example 84. The medical assembly of any example herein, particularlyexample 83, wherein the outer housing includes two or more housingportions that are configured to be removably coupled to one another andcouple together around the anchor and the adaptor.

Example 85. The medical assembly of any example herein, particularlyexample 83 or example 76, wherein the anchor includes an aligning tabconfigured to circumferentially align the adaptor relative to the markerof the distal end portion of the delivery apparatus.

Example 86. The medical assembly of any example herein, particularlyexample 85, wherein the anchor includes a shaft portion defining aninner lumen configured to receive and couple around the proximal endportion of the first shaft and wherein the aligning tab extends radiallyoutward from the shaft portion.

Example 87. The medical assembly of any example herein, particularlyexample 86, wherein anchor includes one or more extension portionsextending radially outward from the shaft portion and configured to matewith corresponding apertures arranged in the outer housing.

Example 88. The medical assembly of any example herein, particularly anyone of examples 68-87, further comprising a third shaft surrounding thefirst shaft, wherein the first shaft is configured to rotate within thethird shaft and the first shaft and third shaft are configured totranslate axially relative to one another, and wherein the third shaftincludes a distal tip portion including a plurality of helical expansiongrooves arranged in an inner surface of the distal tip portion.

Example 89. The medical assembly of any example herein, particularlyexample 88, wherein the distal tip portion is axially movable from afirst position where the distal tip portion is arranged away from andoff the balloon and the distal end portion of the first shaft extendsdistally past a distal end of the distal tip portion to a secondposition where the distal tip portion is arranged over a proximal endportion of the balloon and a distal end portion of the third shaftsurrounds the distal end portion of the first shaft, and wherein theplurality of helical expansion grooves are configured to reduceengagement between pleats of the balloon and the plurality of helicalexpansion grooves when the balloon is rotated with rotation of the firstshaft when the distal tip portion is in the second position.

Example 90. The medical assembly of any example herein, particularlyexample 89, further comprising a distal shoulder arranged within adistal end portion of the balloon and mounted on the distal end portionof the second shaft and wherein, when the distal tip portion is in thefirst position, the distal end portion of the balloon includes a radialdepression that is depressed inward, toward the central longitudinalaxis, relative to an outermost radial surface of the distal shoulder.

Example 91. The medical assembly of any example herein, particularlyexample 82, wherein the radial depression of the distal end portion ofthe balloon is configured to radially expand when the distal tip portionis moved from the first position to the second position.

Example 92. The medical assembly of any of any example herein,particularly example 82 or example 83, wherein the marker is arranged onor embedded within the distal shoulder.

Example 93. The medical assembly of any example herein, particularly anyone of examples 68-92, wherein the prosthetic heart valve includes threecommissures and is configured to be deployed in a native aortic valve.

Example 94. A method, comprising: advancing a distal end portion of adelivery apparatus toward a native valve of a heart, wherein aprosthetic heart valve is radially compressed around an inflatableballoon of the delivery apparatus, at a valve mounting portion of thedelivery apparatus; visualizing, under fluoroscopy and for a selectedimaging view, a position of a radiopaque marker on the distal endportion of the delivery apparatus relative to a guidewire extendingthrough a shaft of the delivery apparatus, wherein the marker iscircumferentially offset from a selected commissure of the radiallycompressed prosthetic heart valve by a predetermined amount that isdetermined based on the selected imaging view, and wherein the marker isreflection asymmetric along an axis that is parallel to a centrallongitudinal axis of the delivery apparatus; prior to crossing thenative valve, rotating the shaft of the delivery apparatus, whichrotates the prosthetic heart valve and the marker, until the marker iscentered along the guidewire and is in a predetermined orientation inthe selected imaging view; and advancing the distal end portion of thedelivery apparatus including the radially compressed prosthetic heartvalve across and into the native valve and inflating the balloon toradially expand and implant the prosthetic heart valve in the nativevalve such that the selected commissure of the prosthetic heart valve isaligned with a target commissure of the native valve, wherein during theinflating, as the prosthetic heart valve radially expands, theprosthetic heart valve rotates.

Example 95. The method of any example herein, particularly example 94,wherein for a first selected imaging view the predetermined amount ofoffset is a first amount and wherein for a second selected imaging viewthe predetermined amount of offset is a second amount.

Example 96. The method of any example herein, particularly example 95,wherein the first selected imaging view is a three-cusp imaging view andthe second selected imaging view is a right/left cusp overlap imagingview and wherein the native valve is a native aortic valve.

Example 97. The method of any example herein, particularly any one ofexamples 94-96, wherein the rotating the shaft of the delivery apparatusincludes rotating a knob disposed on a proximal end portion of the shaftthat extends proximally from a handle of the delivery apparatus andwherein the shaft of the delivery apparatus extends through the handleand distally to the distal end portion of the delivery apparatus.

Example 98. The method of any example herein, particularly example 97,wherein the balloon is coupled to a distal end of the shaft.

Example 99. The method of any example herein, particularly any one ofexamples 94-98, wherein the predetermined orientation in the selectedimaging view is a direct back of the selected imaging view.

Example 100. The method of any example herein, particularly example 99,wherein the marker has a first orientation when it is arranged in frontof the guidewire within the selected imaging view and a different,second orientation when it is arranged behind the guidewire within theselected imaging view and wherein rotating the shaft of the deliveryapparatus, which rotates the prosthetic heart valve and the marker,includes rotating the shaft until the marker is centered along theguidewire and in its second orientation within the selected imagingview, thereby positioning the marker in the direct back of the selectedimaging view.

Example 101. The method of any example herein, particularly any one ofexamples 94-98, wherein the predetermined orientation in the selectedimaging view is a direct front of the selected imaging view.

Example 102. The method of any example herein, particularly example 101,wherein the marker has a first orientation when it is arranged in frontof the guidewire within the selected imaging view and a different,second orientation when it is arranged behind the guidewire within theselected imaging view and wherein rotating the shaft of the deliveryapparatus, which rotates the prosthetic heart valve and the marker,includes rotating the shaft until the marker is centered along theguidewire and in its first orientation within the selected imaging view,thereby positioning the marker in the direct front of the selectedimaging view.

Example 103. The method of any example herein, particularly any one ofexamples 94-102, wherein during the inflating, as the prosthetic heartvalve radially expands, the prosthetic heart valve rotates by an amountequal to the predetermined amount of offset between the marker and theselected commissure of the prosthetic heart valve when the prostheticheart valve is radially compressed around the balloon.

Example 104. The method of any example herein, particularly any one ofexamples 94-103, wherein the shaft is a first shaft, wherein a secondshaft extends through the first shaft and has a distal end portionextending distally beyond a distal end portion of the first shaft, andwherein the marker is arranged on or embedded within a polymeric bodymounted on the distal end portion of the second shaft.

Example 105. The method of any example herein, particularly example 104,wherein the polymeric body is a distal shoulder mounted on the distalend portion of the second shaft, distal to the prosthetic heart valvewhen the prosthetic heart valve is radially compressed around theballoon, and wherein the distal shoulder is configured to resistmovement of the prosthetic heart valve relative to the balloon when theprosthetic heart valve is radially compressed around the balloon.

Example 106. A method, comprising: receiving a prosthetic heart valvemounted on a distal end portion of a delivery apparatus, around aninflatable balloon of the delivery apparatus and in a radiallycompressed configuration, at a predetermined position and in apredetermined orientation relative to the delivery apparatus, such thata selected commissure of the prosthetic heart valve is offset, in acircumferential direction relative to a central longitudinal axis of thedelivery apparatus, from a radiopaque marker on the distal end portionof the delivery apparatus by a predetermined amount, wherein the markeris reflection asymmetric across a longitudinal axis of the marker thatis parallel to the central longitudinal axis; advancing the distal endportion toward a native valve of a heart; prior to crossing the nativevalve with the distal end portion of the delivery apparatus and whileimaging the heart, rotating together, the balloon and the radiallycompressed prosthetic heart valve, until the marker is in a selectedorientation relative to a guidewire extending through a shaft of thedelivery apparatus, within an imaging view; and advancing the radiallycompressed prosthetic heart valve with the delivery apparatus into thenative valve and inflating the balloon to radially expand and implantthe prosthetic heart valve in the native valve such that the selectedcommissure of the prosthetic heart valve is aligned with a targetcommissure of the native valve.

Example 107. The method of any example herein, particularly example 106,wherein the selected orientation includes the longitudinal axis of themarker being axially aligned with the guidewire and the marker being ina first orientation of two orientations that are mirror images of oneanother.

Example 108. The method of any example herein, particularly example 107,wherein the marker is a letter of an alphabet and wherein the firstorientation of the marker is a forward-readable orientation of theletter of the alphabet.

Example 109. The method of any example herein, particularly example 107,wherein the marker is a letter of an alphabet and wherein the firstorientation of the marker is a backward-readable orientation of theletter of the alphabet.

Example 110. The method of any example herein, particularly any one ofexamples 107-109, wherein the selected orientation of the markerindicates the marker is behind the guidewire in the imaging view and themarker is in a back of the imaging view.

Example 111. The method of any example herein, particularly any one ofexamples 107-109, wherein the selected orientation of the markerindicates the marker is in front of the guidewire in the imaging viewand the marker is in a front of the imaging view.

Example 112. The method of any example herein, particularly any one ofexamples 106-111, wherein the rotating includes rotating the shaftwithin and relative to an outer shaft of the delivery apparatus, whereinthe outer shaft is configured to flex.

Example 113. The method of any example herein, particularly any one ofexamples 106-112, wherein the predetermined amount of offset isdetermined based on a radial wrapping of the balloon around the shaft ofthe delivery apparatus and a resulting amount of rotation that occursduring inflating balloon to radially expand the valve.

Example 114. The method of any example herein, particularly example 113,wherein the predetermined amount of offset is further based on theimaging view used during the imaging the heart, the imaging viewselected from a plurality of possible imaging views.

Example 115. The method of any example herein, particularly any one ofexamples 106-114, wherein the marker is arranged on or embedded within apolymeric body mounted on a distal end portion of the shaft of thedelivery apparatus.

Example 116. The method of any example herein, particularly example 115,wherein the polymeric body is a distal shoulder mounted on the distalend portion of the shaft, distal to the prosthetic heart valve, andconfigured to resist movement of the prosthetic heart valve relative tothe balloon.

Example 117. The method of any example herein, particularly any one ofexamples 106-116, wherein the target commissure of the native valve is acommissure between a non-coronary cusp and a left coronary cusp of thenative valve.

Example 118. The method of any example herein, particularly any one ofexamples 106-117, wherein the shaft of the delivery apparatus is a firstshaft that is arranged within and includes a distal end portionextending beyond a distal end portion of a second shaft of the deliveryapparatus and wherein the rotating together, the balloon and theradially compressed prosthetic heart valve includes actuating arotatable knob to rotate the second shaft, the balloon coupled to thedistal end portion of the second shaft.

Example 119. A method, comprising: positioning a prosthetic valve, in aradially expanded state, around a distal end portion of a deliveryapparatus, around an inflatable balloon of the delivery apparatus, at apredetermined position and in a predetermined orientation relative tothe delivery apparatus, such that a selected commissure of theprosthetic valve is offset, in a circumferential direction relative to acentral longitudinal axis of the delivery apparatus, from a radiopaquemarker on the distal end portion of the delivery apparatus by apredetermined amount, wherein the marker is reflection asymmetric alongan axis that is parallel to the central longitudinal axis; and crimpingthe prosthetic valve into a radially compressed state to and around theballoon and the delivery apparatus and maintaining the offset betweenthe selected commissure of the prosthetic valve and the marker.

Example 120. The method of any example herein, particularly example 119,wherein the positioning comprises: positioning the prosthetic valve ontoan implant holder device such that one or more commissures of theprosthetic valve align with one or more corresponding alignment markerson an alignment ring coupled to the implant holder device and couplingthe implant holder device to a first side of a crimping device; andattaching a positioning device to the delivery apparatus and couplingthe positioning device to a second side of the crimping device such thatprosthetic heart valve is positioned around the distal end portion ofthe delivery apparatus, around the balloon, within the crimping device.

Example 121. The method of any example herein, particularly example 120,wherein the prosthetic heart valve, in the radially expanded state, isreceived on a conical support portion of the implant holder device, theconical support portion extending outward from a coupling portion of theimplant holder device, the coupling portion including an alignmentelement configured to mate with a corresponding mating interface in thefirst side of the crimping device.

Example 122. The method of any example herein, particularly example 121,wherein the crimping includes automatically sliding the implant holderdevice away from the prosthetic valve and out of the crimping deviceduring the crimping.

Example 123. The method of any example herein, particularly any one ofexamples 120-122, further comprising selecting the alignment ring fromone or more alignment rings based on a desired imaging view forvisualizing the prosthetic valve on the distal end portion of thedelivery apparatus during an implantation procedure, wherein eachalignment ring of the one or more alignment rings has a differentpredetermined arrangement of the one or more alignment markers on thealignment ring.

Example 124. The method of any example herein, particularly any one ofexamples 120-122, further comprising selecting a set of alignmentmarkers on the alignment ring from multiple sets of alignment markersthat are circumferentially offset from one another, based on a desiredimaging view for visualizing the prosthetic valve on the distal endportion of the delivery apparatus during an implantation procedure andpositioning the prosthetic valve onto the implant holder device suchthat one or more commissures of the prosthetic valve align with one ormore corresponding alignment markers of the selected set of alignmentmarkers on the alignment ring coupled to the implant holder device.

Example 125. The method of any example herein, particularly any one ofexamples 120-122, further comprising selecting a set of alignmentmarkers on the alignment ring from multiple sets of alignment markersthat are circumferentially offset from one another, based on adetermined native anatomy of a heart of a patient in which theprosthetic valve is to be implanted, and positioning the prostheticvalve onto the implant holder device such that one or more commissuresof the prosthetic valve align with one or more corresponding alignmentmarkers of the selected set of alignment markers on the alignment ringcoupled to the implant holder device.

Example 126. The method of any example herein, particularly any one ofexamples 120-125, wherein attaching the positioning device to thedelivery apparatus includes coupling a portion of the positioning devicearound a shaft of the delivery apparatus, proximal to a valve mountingportion of the delivery apparatus and a proximal portion of the balloonof the delivery apparatus.

Example 127. A delivery apparatus, comprising: a first shaft including atapered distal tip portion; a second shaft extending through the firstshaft and configured to rotate within the first shaft, around a centrallongitudinal axis of the delivery apparatus, wherein the first shaft andthe second shaft are configured to translate axially relative to oneanother; a third shaft extending through the second shaft and having adistal end portion extending distally beyond a distal end portion of thesecond shaft; an inflatable balloon coupled to the distal end portion ofthe second shaft, the balloon arranged around the distal end portion ofthe third shaft and overlaying a valve mounting portion of the deliveryapparatus that is configured to receive a prosthetic valve in a radiallycompressed state; and wherein the distal tip portion of the first shaftincludes a proximal end portion and a distal end portion that has anouter diameter than increases in a distal direction, the distal endportion including a plurality of helical internal grooves arranged on aninner surface of the distal end portion, the plurality of helicalinternal grooves configured to reduce engagement between pleats of theballoon and the plurality of helical internal grooves when the balloonis rotated with rotation of the second shaft.

Example 128. The delivery apparatus of any example herein, particularlyexample 127, wherein the helical internal grooves of the plurality ofhelical internal grooves are spaced apart from one another around acircumference of the distal tip portion and wherein each helicalinternal groove of the plurality of helical internal grooves curvesaround the central longitudinal axis.

Example 129. The delivery apparatus of any of any example herein,particularly example 128, wherein the distal end portion of the distaltip portion includes a plurality of helical external grooves arranged onan outer surface of the distal end portion and spaced apart from oneanother around a circumference of the distal tip portion.

Example 130. The delivery apparatus of any example herein, particularlyexample 129, wherein the plurality of helical internal grooves arecircumferentially offset from the plurality of helical external groovessuch that a location where one helical external groove depresses intothe outer surface of the distal tip portion is arranged between wheretwo adjacent helical internal grooves of the plurality of helicalinternal grooves depress into the inner surface of the distal tipportion.

Example 131. The delivery apparatus of any example herein, particularlyany one of examples 127-130, wherein the distal tip portion is axiallymovable from a first position where the distal tip portion is arrangedaway from and off the balloon and the distal end portion of the secondshaft extends distally past a distal end of the distal tip portion to asecond position wherein the distal tip portion is arranged over aproximal end portion of the balloon and adjacent to a proximal side ofthe valve mounting portion.

Example 132. The delivery apparatus of any example herein, particularlyexample 131, wherein the distal tip portion is configured to resistmovement of the prosthetic valve relative to the balloon in an axialdirection when the distal tip portion is in the second position.

Example 133. The delivery apparatus of any of any example herein,particularly example 132, further comprising a distal shoulder arrangedwithin a distal end portion of the balloon and mounted on the distal endportion of the third shaft, wherein the distal shoulder includes aflared portion arranged adjacent to the valve mounting portionconfigured such that when the prosthetic valve is mounted on the balloonin the radially compressed state, the distal shoulder resists movementof the prosthetic valve relative to the balloon in an axial direction.

Example 134. The delivery apparatus of any example herein, particularlyexample 133, wherein, when the distal tip portion is in the firstposition, the distal end portion of the balloon includes a radialdepression that is depressed radially inward, toward the centrallongitudinal axis, relative to an outermost radial surface of the flaredportion of the distal shoulder.

Example 135. The delivery apparatus of any example herein, particularlyexample 134, further comprising a nose cone mounted on the distal endportion of the third shaft, distal to the distal shoulder, and whereinthe distal end portion of the balloon extends over the flared portion ofthe distal shoulder, then depress radially inward, toward a base portionof the distal shoulder, and then extends back radially outward to aproximal end of the nose cone to form the radial depression.

Example 136. The delivery apparatus of any example herein, particularlyexample 134 or example 135, wherein the radial depression of the distalend portion of the balloon is configured to radially expand when thedistal tip portion is moved from the first position to the secondposition.

Example 137. The delivery apparatus of any example herein, particularlyany one of examples 133-136, wherein a radiopaque marker is arranged onor embedded within the distal shoulder.

Example 138. The delivery apparatus of any example herein, particularlyany one of examples 133-137, wherein a radiopaque marker is arranged onor embedded within the flared portion of the distal shoulder.

Example 139. The delivery apparatus of any example herein, particularlyexample 137 or example 138, wherein the radiopaque marker is asymmetricacross an axis that is parallel to the central longitudinal axis.

Example 140. The delivery apparatus of any example herein, particularlyany one of examples 127-139, wherein the second shaft comprises a firstlayer of braided material and a second layer of braided materialembedded therein, wherein the first layer of braided material extendsalong an entire length of the second shaft, from a proximal end to adistal end of the second shaft, and the second layer of braided materialextends a majority of the entire length of the second shaft, from theproximal end to a distance spaced away from the distal end.

Example 141. The delivery apparatus of any example herein, particularlyany one of examples 127-140, further comprising: a handle portion,wherein the second shaft extends distally from the handle portion andhas a proximal end portion that extends proximally from the handleportion; and a knob mounted on the proximal end portion of the secondshaft and configured to rotate the second shaft relative to the firstshaft.

Example 142. The delivery apparatus of any example herein, particularlyexample 141, further comprising an adaptor coupled to the proximal endportion of the second shaft, the adaptor including a body coupled to theproximal end portion of the second shaft, a first port extending axiallyfrom the body, relative to the central longitudinal axis, and a secondport extending at an angle from the body, relative to the centrallongitudinal axis.

Example 143. The delivery apparatus of any example herein, particularlyexample 142, wherein an inner lumen of the second port is fluidlycoupled to an annular space defined between an inner surface of thesecond shaft and an outer surface of the third shaft and a fluidpassageway formed between the outer surface of the distal end portion ofthe third shaft and an inner surface of the balloon.

Example 144. The delivery apparatus of any example herein, particularlyexample 142 or example 143, wherein the second port is configured torotate around the central longitudinal axis and relative to the body andthe first port of the adaptor.

Example 145. The delivery apparatus of any example herein, particularlyany one of examples 142-144, wherein the knob comprises an outer housingand an anchor arranged within the outer housing, wherein the anchor isconfigured to couple the knob to the proximal end portion of the secondshaft.

Example 146. The delivery apparatus of any example herein, particularlyexample 145, wherein the outer housing includes two or more housingportions that are configured to be removably coupled to one another andcouple together around the anchor.

Example 147. The delivery apparatus of any example herein, particularlyexample 145 or example 146, wherein the anchor includes an aligning tabconfigured to align the adaptor relative to a radiopaque marker arrangedon or embedded within a polymeric body mounted to the distal end portionof the third shaft.

Example 148. The delivery apparatus of any example herein, particularlyexample 147, wherein the anchor includes a shaft portion defining aninner lumen configured to receive and couple around the proximal endportion of the second shaft and wherein the aligning tab extendsradially outward from the shaft portion.

Example 149. The delivery apparatus of any example herein, particularlyexample 148, wherein the shaft portion of the anchor includes one ormore centering ribs spaced apart around a circumference of the innerlumen and extending along the inner lumen.

Example 150. The delivery apparatus of any example herein, particularlyexample 147 or example 148, wherein a distal end of the shaft portion ofthe anchor includes one or more radial extensions extending around acircumference of the shaft portion and spaced apart from one another, inan axial direction, and wherein the one or more radial extensions areconfigured to mate with an interior of a sleeve element arranged aroundthe proximal end portion of the second shaft and the distal end of theshaft portion of the anchor, the sleeve element configured to relievestrain between the knob and the proximal end portion of the secondshaft.

Example 151. The delivery apparatus of any example herein, particularlyany one of examples 127-150, wherein the balloon includes a plurality ofoverlapping pleats wrapped around the second shaft.

Example 152. A delivery apparatus, comprising: a handle portion; arotatable shaft extending distally from the handle portion and having aproximal end portion that extends proximally from the handle portion toan adaptor, the adaptor including a body connected to the proximal endportion, a first port extending axially from the body, and a second portextending at an angle from the body, in a direction intersecting acentral longitudinal axis of the delivery apparatus; a knob mounted onthe proximal end portion of the rotatable shaft, the knob configured torotate the rotatable shaft; and an inflatable balloon coupled to adistal end portion of the rotatable shaft and configured to inflate uponreceiving inflation fluid from the second port.

Example 153. The delivery apparatus of any example herein, particularlyexample 152, wherein the handle portion includes one or more adjustmentmembers configured to control operation of the delivery apparatus.

Example 154. The delivery apparatus of any example herein, particularlyexample 152, wherein a first adjustment member of the one or moreadjustment members is configured as a rotatable knob that is configuredto adjust a curvature of a distal end portion of the delivery apparatus.

Example 155. The delivery apparatus of any example herein, particularlyexample 153 or example 154, wherein a second adjustment member of theone or more adjustment members is configured as a rotatable knobconfigured to adjust an axial position of the rotatable shaft relativeto an outer shaft of the delivery apparatus that surrounds the rotatableshaft.

Example 156. The delivery apparatus of any example herein, particularlyany one of examples 152-155, wherein the second port is rotatable aroundand relative to the body of the adaptor.

Example 157. The delivery apparatus of any example herein, particularlyexample 156, wherein the second port includes a base portion arrangedaround a circumference of a proximal portion of the body of the adaptorand wherein the second port includes an inner channel extending from anopening in the second port, through a shaft portion of the second port,and through a portion of the base portion connected with the shaftportion.

Example 158. The delivery apparatus of any example herein, particularlyexample 157, wherein a seal is arranged between the base portion and theproximal portion of the body of the adaptor.

Example 159. The delivery apparatus of any example herein, particularlyexample 157 or example 158, wherein the proximal portion of the body ofthe adaptor includes an annular groove defining an annular channelextending around at least a portion of a circumference of the proximalportion of the body of the adaptor, wherein the annular channel isconfigured to fluidly couple the inner channel to an interior of theballoon.

Example 160. The delivery apparatus of any example herein, particularlyexample 159, wherein the annular channel fluidly couples the innerchannel to an annular space defined between an outer surface of an innershaft of the delivery apparatus extending through the rotatable shaftand through the proximal portion of the body of the adaptor and an innersurface of the proximal portion of the body of the adaptor.

Example 161. The delivery apparatus of any example herein, particularlyany one of examples 157-160, wherein the proximal portion of the body ofthe adaptor is bonded to the first port.

Example 162. The delivery apparatus of any example herein, particularlyany one of examples 152-161, wherein the adaptor is connected to theproximal end portion of the rotatable shaft by a shaft connector releaseassembly, the shaft connector release assembly comprising: a releasesleeve directly coupled to the proximal end portion of the rotatableshaft; and an adaptor insert directly coupled to the adaptor, whereinthe release sleeve is received within an interior cavity of the adaptorinsert.

Example 163. An assembly comprising: an adaptor connecting portionconfigured to be coupled to or integrally formed with an adaptor; anadaptor insert configured to be received within an interior cavity ofthe adaptor connecting portion and comprising an interior cavityincluding a plurality of cavity portions, the plurality of cavityportions including a first cavity portion with a first diameter and asecond cavity portion with a second diameter, the second diametersmaller than the first diameter; and a release sleeve comprising awider, first portion configured to be received within the first cavityportion and a narrower, second portion configured to be received withinthe second cavity portion, wherein the second portion of the releasesleeve is configured to bend radially inward relative to a centrallongitudinal axis of the assembly.

Example 164. The assembly of any example herein, particularly example163, wherein the second portion of the release sleeve comprises a bodythat narrows from the first portion of the release sleeve to a wider,collar portion of the second portion of the release sleeve.

Example 165. The assembly of any example herein, particularly example164, wherein the collar portion extends radially outward from a narrowerportion of the body of the second portion of the release sleeve to anend of the release sleeve and wherein the collar portion has a thirddiameter at the end of the release sleeve which is larger than a fourthdiameter of a wider portion of the body that is disposed adjacent to thefirst portion of the release sleeve.

Example 166. The assembly of any example herein, particularly example165, wherein, when the release sleeve is arranged outside of the adaptorinsert, the third diameter of the collar portion is greater than thesecond diameter of the second cavity portion of the adaptor insert andwherein, when the release sleeve is received within the interior cavityof the adaptor insert and the collar portion is arranged within thesecond cavity portion, the third diameter of the collar portion issmaller or equal to the second diameter of the second cavity portion.

Example 167. The assembly of any example herein, particularly example164 or example 236, wherein the second portion of the release sleevecomprises one or more slots that extend axially through the body and thecollar portion of the second portion of the release sleeve and whereinthe one or more slots are configured to enable the second portion of therelease sleeve to bend radially inward.

Example 168. The assembly of any example herein, particularly example167, wherein the one or more slots include a plurality of slots that arespaced apart from one another around a circumference of the secondportion of the release sleeve.

Example 169. The assembly of any example herein, particularly any one ofexamples 163-168, wherein the interior cavity of the adaptor insertfurther includes a third cavity portion with a fifth diameter that islarger than the first diameter and wherein the first portion of therelease sleeve comprises a flange that is configured to be receivedwithin the third cavity portion.

Example 170. The assembly of any example herein, particularly any one ofexamples 163-169, further comprising a sealing member disposed within afourth cavity portion of the interior cavity of the adaptor insert, thefourth cavity portion disposed adjacent to the second cavity portion andhaving a sixth diameter that is larger than the second diameter of thesecond cavity portion.

Example 171. The assembly of any example herein, particularly any one ofexamples 163-169, further comprising a shaft received within the releasesleeve and coupled to the release sleeve at the second portion of therelease sleeve and wherein the shaft is coupled to the adaptorconnecting portion by the release sleeve and the adaptor insert.

Example 172. A delivery apparatus comprising: a handle portion; arotatable shaft extending distally from the handle portion and having aproximal end portion that extends proximally from the handle portion; anadaptor in fluid communication with an inner lumen of the rotatableshaft; a shaft connector release assembly coupling the proximal endportion of the rotatable shaft to the adaptor, the shaft connectorrelease assembly comprising: an adaptor insert coupled to the adaptorand comprising an interior cavity; and a release sleeve disposed aroundthe proximal end portion of the rotatable shaft and positioned withinthe interior cavity of the adaptor insert, the release sleeve coupled tothe adaptor insert, wherein a flexible, first portion of the releasesleeve is depressed radially inward and held in coupling contact withthe proximal end portion of the rotatable shaft via radially inwardpressure from the adaptor insert; and an inflatable balloon coupled to adistal end portion of the rotatable shaft and configured to inflate uponreceiving inflation fluid from the adaptor.

Example 173. The delivery apparatus of any example herein, particularlyexample 172, wherein the release sleeve comprises the first portion anda second portion and wherein the second portion is larger in diameterthan the first portion.

Example 174. The delivery apparatus of any example herein, particularlyexample 173, wherein the first portion of the release sleeve comprises abody that narrows from the second portion of the release sleeve to awider, collar portion of the first portion of the release sleeve.

Example 175. The delivery apparatus of any example herein, particularlyexample 174, wherein the collar portion extends radially outward from anarrower portion of the body of the first portion of the release sleeveto an end of the release sleeve and wherein, when the release sleeve isarranged outside of the adaptor insert, a diameter of the collarportion, at the end of the release sleeve, is larger than a diameter ofa wider portion of the body that is disposed adjacent to the secondportion of the release sleeve.

Example 176. The delivery apparatus of any example herein, particularlyexample 174 or example 175, wherein the first portion of the releasesleeve comprises one or more slots that extend axially through the bodyand the collar portion of the first portion of the release sleeve andwherein the one or more slots are configured to enable the first portionof the release sleeve to bend radially inward.

Example 177. The delivery apparatus of any example herein, particularlyexample 176, wherein the one or more slots include a plurality of slotsthat are spaced apart from one another around a circumference of thesecond portion of the release sleeve.

Example 178. The delivery apparatus of any example herein, particularlyany one of examples 173-177, wherein the interior cavity of the adaptorinsert includes a plurality of cavity portions, the plurality of cavityportions including a first cavity portion with a first diameter and asecond cavity portion with a second diameter, the second diametersmaller than the first diameter and wherein the second portion of therelease sleeve is disposed within the first cavity portion and the firstportion of the release sleeve is disposed within the second cavityportion.

Example 179. The delivery apparatus of any example herein, particularlyexample 178, wherein the shaft connector release assembly furthercomprises a sealing member disposed within a third cavity portion of theinterior cavity of the adaptor insert and disposed around an outersurface of the proximal end portion of the rotatable shaft, the thirdcavity portion disposed adjacent to the second cavity portion and havinga third diameter that is larger than the second diameter of the secondcavity portion.

Example 180. The delivery apparatus of any example herein, particularlyany one of examples 172-179, wherein the shaft connector releaseassembly further comprises a sealing member disposed around the proximalend portion of the rotatable shaft and within the interior cavity of theadaptor insert, adjacent to an end of the first portion of the releasesleeve.

Example 181. The delivery apparatus of any example herein, particularlyany one of examples 172-180, wherein the adaptor insert is configured tobe received within an interior cavity of a connecting portion of theadaptor.

Example 182. The delivery apparatus of any example herein, particularlyany one of examples 172-181, further comprising a knob mounted on theproximal end portion of the rotatable shaft, distal to the adaptor, theknob configured to rotate the rotatable shaft.

In view of the many possible embodiments to which the principles of thedisclosed technology may be applied, it should be recognized that theillustrated embodiments are only preferred examples of the disclosedtechnology and should not be taken as limiting the scope of the claimedsubject matter. Rather, the scope of the claimed subject matter isdefined by the following claims and their equivalents.

We claim:
 1. A delivery apparatus comprising: a first shaft configured to rotate around a central longitudinal axis of the delivery apparatus to rotationally align a prosthetic valve mounted on the delivery apparatus with native anatomy at a target implantation site; a second shaft extending through the first shaft and having a distal end portion extending distally beyond a distal end portion of the first shaft; an inflatable balloon coupled to the distal end portion of the first shaft; and a third shaft surrounding the first shaft, wherein the first shaft is configured to rotate within the third shaft, wherein the first shaft and third shaft are configured to translate axially relative to one another, and wherein the third shaft includes a distal tip portion including a plurality of internal helical expansion grooves and a plurality of external helical expansion grooves that are configured to allow the distal tip portion to flex radially outward.
 2. The delivery apparatus of claim 1, wherein the distal tip portion comprises a coupling portion mounted around a distal end of the first shaft and a flex portion extending distally outward from the coupling portion, and wherein the plurality of internal helical expansion grooves are arranged in an inner surface of the flex portion and curve around the central longitudinal axis, from a proximal end of the flex portion to a distal end of the distal tip portion.
 3. The delivery apparatus of claim 2, wherein the distal tip portion is axially movable from a first position where the distal tip portion is arranged away from and off the balloon and the distal end portion of the first shaft extends distally past the distal end of the distal tip portion, to a second position wherein the distal tip portion is arranged over a proximal end portion of the balloon and a distal end portion of the third shaft surrounds the distal end portion of the first shaft, and wherein the plurality of internal helical expansion grooves are configured to reduce engagement between pleats of the balloon and the plurality of internal helical expansion grooves when the balloon is rotated with rotation of the first shaft when the distal tip portion is in the second position.
 4. The delivery apparatus of claim 3, further comprising a distal shoulder mounted on the distal end portion of the second shaft and arranged within a distal end portion of the balloon, wherein the distal shoulder is configured to resist movement of the prosthetic valve relative to the balloon in an axial direction.
 5. The delivery apparatus of claim 4, wherein, when the distal tip portion is in the first position, a distal end portion of the balloon includes a radial depression that is depressed inward, toward the central longitudinal axis, relative to an outermost radial surface of the distal shoulder.
 6. The delivery apparatus of claim 5, wherein the radial depression of the distal end portion of the balloon is configured to radially expand when the distal tip portion is moved from the first position to the second position.
 7. The delivery apparatus of claim 5, wherein the distal shoulder comprises a base portion and a flared portion that extends radially outward from the base portion such that the flared portion is disposed radially outward from an outer surface of the second shaft.
 8. The delivery apparatus of claim 7, wherein a radiopaque marker is mounted on or embedded within the flared portion of the distal shoulder.
 9. The delivery apparatus of claim 8, wherein the marker is reflection asymmetric along an axis that is parallel to the central longitudinal axis.
 10. The delivery apparatus of claim 1, further comprising a handle portion including a steering mechanism configured to selectively adjust a curvature of the third shaft.
 11. The delivery apparatus of claim 1, further comprising a handle including one or more adjustment mechanisms configured to adjust operation of the delivery apparatus, wherein the first shaft extends distally from the handle to the distal end portion of the first shaft, wherein the first shaft has a proximal end portion that extends proximally from the handle to an adaptor, and further comprising a rotatable knob mounted on the proximal end portion of the first shaft, the knob configured to rotate the first shaft.
 12. The delivery apparatus of claim 1, wherein the balloon includes a plurality of overlapping pleats wrapped around the second shaft and overlaying a valve mounting portion of the delivery apparatus, the valve mounting portion configured to receive the prosthetic valve in a radially compressed state.
 13. A delivery apparatus comprising: a first shaft including a tapered distal tip portion; a second shaft extending through the first shaft and configured to rotate within the first shaft, around a central longitudinal axis of the delivery apparatus, wherein the first shaft and the second shaft are configured to translate axially relative to one another; a third shaft extending through the second shaft and having a distal end portion extending distally beyond a distal end portion of the second shaft; and an inflatable balloon coupled to the distal end portion of the second shaft, the balloon arranged around the distal end portion of the third shaft and overlaying a valve mounting portion of the delivery apparatus that is configured to receive a prosthetic valve in a radially compressed state; wherein the distal tip portion of the first shaft includes a proximal end portion and a distal end portion that has an outer diameter than increases in a distal direction, the distal end portion including a plurality of helical internal grooves arranged on an inner surface of the distal end portion, the plurality of helical internal grooves configured to reduce engagement between pleats of the balloon and the plurality of helical internal grooves when the balloon is rotated with rotation of the second shaft.
 14. The delivery apparatus of claim 13, wherein the helical internal grooves of the plurality of helical internal grooves are spaced apart from one another around a circumference of the distal tip portion, and wherein each helical internal groove of the plurality of helical internal grooves curves around the central longitudinal axis.
 15. The delivery apparatus of claim 13, wherein the distal end portion of the distal tip portion includes a plurality of helical external grooves arranged on an outer surface of the distal end portion and spaced apart from one another around a circumference of the distal tip portion.
 16. The delivery apparatus of claim 15, wherein the plurality of helical internal grooves is circumferentially offset from the plurality of helical external grooves such that a location where one helical external groove depresses into the outer surface of the distal tip portion is arranged between where two adjacent helical internal grooves of the plurality of helical internal grooves depress into the inner surface of the distal tip portion.
 17. The delivery apparatus of claim 13, wherein the distal tip portion is axially movable from a first position where the distal tip portion is arranged away from and off the balloon and the distal end portion of the second shaft extends distally past a distal end of the distal tip portion, to a second position wherein the distal tip portion is arranged over a proximal end portion of the balloon and adjacent to a proximal side of the valve mounting portion.
 18. The delivery apparatus of claim 17, wherein the distal tip portion is configured to resist movement of the prosthetic valve relative to the balloon in an axial direction when the distal tip portion is in the second position.
 19. The delivery apparatus of claim 18, further comprising a distal shoulder arranged within a distal end portion of the balloon and mounted on the distal end portion of the third shaft, wherein the distal shoulder includes a flared portion arranged adjacent to the valve mounting portion configured such that when the prosthetic valve is mounted on the balloon in the radially compressed state, the distal shoulder resists movement of the prosthetic valve relative to the balloon in an axial direction.
 20. A delivery apparatus comprising: a first shaft configured to rotate around a central longitudinal axis of the delivery apparatus to rotationally align a prosthetic valve mounted on the delivery apparatus with native anatomy at a target implantation site; a second shaft extending through the first shaft and having a distal end portion extending distally beyond a distal end portion of the first shaft; an inflatable balloon coupled to the distal end portion of the first shaft; a polymeric body mounted on the distal end portion of the second shaft and a radiopaque marker mounted on or embedded within the polymeric body; and a third shaft surrounding the first shaft, wherein the first shaft is configured to rotate within the third shaft, wherein the first shaft and third shaft are configured to translate axially relative to one another, and wherein the third shaft includes a distal tip portion including a plurality of helical expansion grooves arranged in an inner surface of the distal tip portion and configured to allow the distal tip portion to flex radially outward, wherein the distal tip portion is axially movable from a first position where the distal tip portion is arranged away from and off the balloon and the distal end portion of the first shaft extends distally past a distal end of the distal tip portion to a second position where the distal tip portion is arranged over a proximal end portion of the balloon and a distal end portion of the third shaft surrounds the distal end portion of the first shaft, and wherein the plurality of helical expansion grooves are configured to reduce engagement between pleats of the balloon and the plurality of helical expansion grooves when the balloon is rotated with rotation of the first shaft when the distal tip portion is in the second position. 